Advice
PD-UserHbk-01
Tests Requesting
Departments About Us
About Us Departments Requesting
About Us
Contacts Quality
Departments
Requesting
Phlebotomy Point of Care
Making a request Labelling Transport
Tests
Tests
Advice Advice
Overview
Test Information Profiles
Clinical Info Complaints Results
Directorate of Pathology Welcome to the Pathology Laboratory Handbook. The directorate of Pathology at Doncaster and Bassetlaw Hospitals encompass the Departments of Clinical Biochemistry, Haematology, Histopathology, Cytology, Morbid Anatomy, Microbiology, Immunology and Virology. An open access (not 24 hours) Phlebotomy service is also provided. We have produced this handbook to provide information which will allow you to make best use of our services.
The handbook updates will always be available at the Doncaster and Bassetlaw Hospitals website www.dbh.nhs.uk Using the handbook Pre-requisites The Handbook is distributed in Adobe Acrobat format. It is capable of being read on a variety of devices which support this format. The reader is readily and freely available on the Adobe website. If you have difficult installing the reader, contact your IT support.
Advice
Tests
Requesting
Departments
About Us
This new format handbook is designed to be used in an electronic format. Printed copies will not be available, as it is impossible to ensure that paper copies are kept current.
The handbook makes use of the facilities that are built into the Acrobat Reader software. When the handbook starts up, it will always open on the first page, and be zoomed so that it is possible to see the entire first page on screen at once. Browsing The page browser toolbar allows you to one page to the next. The single blue arrows are to go forward and back to the next or previous pages. Author Title Document No.
Peter J Taylor Pathology Handbook Introduction PD-UserHbk-007 ver1.0
step from
Page 1 of 3 1/4/2008
The arrow and bar symbols are to go to the first or last pages in the document. The green buttons are to go forward and back in visited pages. Bookmarks To the left of the handbook pages is a pane which shows the Bookmarks that have been created in the Handbook to make finding information more straightforward. These colour coded bookmarks give shortcuts to the various sections within the Handbook, and then each section has subordinate markers which go to particular pages within the section. This includes bookmarks for all tests that the directorate offers. Clicking the X at the top of the Bookmark pane will hide the bookmarks and allow you to have a larger view of the screen. Pressing the Bookmarks tab will open this pane back up again. The handbook always opens with the Bookmarks pane showing.
• • • •
Click on the Search Icon on the toolbar A second pane will pop up on the right of the screen. In the first box type in the phrase or word you wish to look for. Press Search. A list of matches then comes up in the pane.
Requesting
Departments
About Us
Searching It is possible to use the Search facilities to find particular words or phrases in the handbook.
Tests
The above example shows a search for FBC (Full Blood Count) The software takes you to the first instance of the searched item. Clicking on each of the items in the results will take you to the page they are on, and will highlight the search text. If you wish to do another search, press the New Search button.
Advice
When you have finished searching, use the Hide button to close the pane. Pages If you click the Pages tab to the side of the Bookmarks pane, the view will change to a set of thumbnails which show you what each page looks like. It is too small to see any text, but is useful for finding pages with graphical content such as the Maps in the Appendices. Other toolbar functions Author Title Document No.
Peter J Taylor Pathology Handbook Introduction PD-UserHbk-007 ver1.0
Page 2 of 3 14/06/2007
Zooming Use the Zoom buttons to set the amount of each page that can be viewed. By default, the screen always fits to a page width, the view can be modified to zoom to a particular section (Use the magnifying glass tool), To page height, page width, or use the – and + buttons to zoom to a particular size. Highlighting and copying text If you wish to copy a piece of information from the handbook text, use the Select button . Once this is pressed, mark around the text by highlighting, and then press Copy from the Edit Menu on the menu bar. It is then possible to Paste this information into another document. Remember however that this will no longer be kept up to date.
Problems If you have any problems with this application, please contact Peter Taylor at DRI (01302 381449)
Advice
Tests
Requesting
Departments
About Us
Printing Because of document control, it is undesirable to have printed copies of the handbook available, as they would soon be out of date. For this reason it is not possible to print from the handbook, and the print icon has been disabled.
Author Title Document No.
Peter J Taylor Pathology Handbook Introduction PD-UserHbk-007 ver1.0
Page 3 of 3 14/06/2007
Directorate of Pathology What’s New The following items have been revised since the last version of the Laboratory Handbook. The Laboratory Handbook had a major new release dated April 2008. The latest release is dated June 2008. eGFR Estimated Glomerular Filtration Rate is shown as part of the U&E Test Set. There is now an entry in the Tests section for eGFR which includes a calculator (compensated for DBH Creatinine values) and clinical advice.
-
Blood Cultures The section on blood cultures incorporates the latest clinical advice.
Advice
Tests
Requesting
Departments
About Us
-
Author Title
Peter J Taylor Handbook New Itens
Page 1 of 1 06/06/2008
About Us
About Us
Overview Contacts Quality
This section contains information about the laboratory quality policy, contact information, laboratory structure and opening hours
Directorate of Pathology About Us Pathology Directorate of The Doncaster & Bassetlaw Hospitals NHS Foundation Trust The Pathology Directorate is part of Doncaster & Bassetlaw Hospitals NHS Foundation Trust (DBHFT) which was formed on the 1st April 2001 and became a first wave Foundation Trust on 1st April 2004. The Directorate of Laboratory Medicine is registered with the Clinical Pathology Accreditation (UK) Ltd (CPA). The departments in the Directorate have been assessed by CPA at regular intervals and are accredited accordingly. The accreditation standards include the operation of a quality management system to ensure that all aspects of the service operate to provide a service that is responsive to the needs and requirements of users.
About Us
It is a twin sited pathology directorate serving a network of five hospitals plus two Primary Care Trusts serving a population of 410,000. Three hospitals are owned by the Trust: Bassetlaw Hospital (BDGH), Doncaster Royal Infirmary (DRI) and Montagu Hospital. Outpatient services are provided at Retford Hospital (owned by Bassetlaw Primary Care Trust), and elderly rehabilitation services at Tickhill Road Hospital (owned by Doncaster and South Humber Healthcare NHS Trust). The Pathology Service encompasses two main laboratories located on the Doncaster Royal Infirmary (DRI) and Bassetlaw District General (BDGH) Hospitals sites with an additional facility of a small specimen reception area and limited equipment located at Mexborough Montagu hospital. The Commission for Healthcare Audit & Improvement (CHAI) has given the DBHFT the top 3-star rating for the last six years (2001-2006). The Trust has received a Top40 Hospitals award in each of the last seven years from the independent health benchmark organisation, CHKS. All five sites where the Trust provides services were accredited with the Charter Mark standard in November 2004. At its annual review, the Trust was found to be still meeting the standards so the award was extended until 2008. All services and facilities provided by the Trust can be found on the Doncaster & Bassetlaw Hospitals NHS Foundation Trust website. http://www.dbh.nhs.uk Postal Addresses Doncaster Site: Pathology Directorate Doncaster Royal Infirmary Armthorpe Road Doncaster DN2 5LT Tel: Fax:
01302 553131 01302 553132
Bassetlaw Site: Pathology Directorate Bassetlaw District General Hospital Kilton Worksop S81 0BD Tel: Fax:
01909 500990 01909 502462
Mexborough Site: Pathology Laboratory Montagu Hospital Adwick Road Mexborough Doncaster S64 0AZ Tel:
01709 585171 ext 5235
Author Title Document No.
Peter J Taylor About Us PD-UserHbk-008 ver 1.0
Page 1 of 3 1/4/2008
Directorate of Pathology Opening Hours Monday to Friday Saturday, Sunday, Bank Holiday and after 17:00 Monday – Friday Histopathology does not operate an out of hours service.
- 09:00 – 17:00 - on-call BMS service
The Pathology Directorate is responsible for the provision of pathology laboratory services to Primary and Secondary Care throughout the Doncaster and Bassetlaw districts. The Directorate is committed to providing a service of the highest quality and is aware of and takes into consideration the needs and requirements of its users.
About Us
In its pursuit of excellence and as part of its continuous quality improvement programme the Pathology Directorate participates in all relevant internal and external quality assurance schemes. All laboratory work is carried out on up to date equipment in modern laboratories which meet with all statutory requirements. The Pathology Directorate encompasses the Departments of Clinical Biochemistry, Haematology, Histopathology, Cytology, Morbid Anatomy, Microbiology, Immunology and Virology. An open access (8.30am – 5pm) Phlebotomy service is provided for outpatients and GP patients at all sites with a mornings only phlebotomy service available to the wards at Bassetlaw DGH and Doncaster Royal site, seven days per week and Mexborough Montagu Monday to Friday. The departments of Clinical Biochemistry, Haematology and Microbiology share the same specimen reception area and request forms. Histopathology and Cytology departments are located only at Doncaster Royal infirmary site and have their own request forms and specimen reception arrangements. The pathology services are fully computerised with all laboratories using a Quadramed Omnilab Computer system with a fully integrated database across all pathology disciplines. All wards have access to the Quadramed system using VDU’s. Pathology results are available electronically via the Trust PAS at ward level or via the GP electronics links. Hard copies are returned daily Monday-Friday. Summary of Departmental services: a) Mexborough Montagu Hospital This site is equipped with an acute testing instrument capable of measuring blood gases, electrolytes and glucose on whole blood samples. This facility is co-ordinated via the Clinical Biochemistry department at the Doncaster Royal Infirmary site. All other tests are performed at the Doncaster Royal Infirmary site after sample preparation in the Montagu laboratory. There is a fully alarmed Blood Bank storage fridge on site co-ordinated via the Blood Bank department at Doncaster Royal Infirmary site. b) Clinical Biochemistry & Immunology The Clinical Biochemistry department is split over two sites; Doncaster (DRI) and Bassetlaw Hospitals, with an Immunology service centralised at DRI. The range and volume of test requests reflects the usual demands of a large District General hospital service. A high proportion of the available tests are performed in house. The department provides antenatal screening services to hospital and the community and supports blood gas analysers that are sited on Intensive Care and Special Care Baby Units. The department’s equipment includes Olympus AU2700’s, Bayer Centaurs, Abbott Architect, DPC Immulite, Radiometer and AVL blood gas machines and Biorad HbA1c analysers. The department participates in a variety of internal and external audit activities within both the Trust and region and also subscribes to national external quality assessment schemes.
Author Title Document No.
Peter J Taylor About Us PD-UserHbk-008 ver 1.0
Page 2 of 3 1/4/2008
Directorate of Pathology c) Haematology The Haematology department is split over two sites providing a routine Haematology (including Microscopy and Haematinics), Coagulation (including Thrombophilia at Doncaster Royal Site), Anticoagulation and Blood Transfusion service to users. Both sites are equipped with Sysmex Haematology analysers, Biomerieux Coagulation analysers and Diamed Blood Bank analysers. The department participates in a variety of internal and external audit activities both within the Trust and region and also subscribes to national external quality assessment schemes. Practices are also in place to address standards introduced with the Blood Safety and Quality Regulations 2005. In November 2006, the Blood Bank was subject to a successful MHRA assessment against these new standards.
About Us
d) Histopathology / Cytology Department All Histopathology and cytology is processed and reported at the Doncaster Royal Infirmary site (basement corridor). Morbid Anatomy services are provided at both the Doncaster Royal and Bassetlaw District hospital sites. Histopathology processes over 24,000 surgical, systemic cytology and post mortem requests a year, producing in the region of 45,000 wax blocks. Approximately 60,000 Haematoxylin and Eosin and special stain slides are produced. The cervical cytology department screens approximately 37,000 smears per year. Cervical cytology statistical analysis indicates the reporting and abnormal pick up rates fall within national parameters. Morbid Anatomy services are registered with the Human Tissue Authority for: • The making of a post-mortem examination (DRI & BDGH Sites) •
The removal from the body of a deceased person of relevant material of which the body consists or which it contains, for use for a Scheduled Purpose other than transplantation (DRI & BDGH sites)
•
The storage of the body of a deceased person, or relevant material which has come from a human body, for use for a Scheduled Purpose (DRI, BDGH & Mex sites)
Licencing number – 12268 Designated Individual – Dr Emyr Jones (Medical Director) Licence Holder - Doncaster & Bassetlaw Hospitals NHS Foundation Trust e) Microbiology & Virology The Microbiology Department has modern purpose built laboratories providing a comprehensive service at both sites in Microbiology including Mycology and Parasitology. Virology and Serology are centralised at the Bassetlaw site and Mycobacteriology at the Doncaster site. Specialist and Reference test services are used where necessary and there is a collaborative Clinical, Infection Control and Biomedical Scientist service.
Author Title Document No.
Peter J Taylor About Us PD-UserHbk-008 ver 1.0
Page 3 of 3 1/4/2008
Directorate of Pathology Contacts RESULT ENQUIRIES IN ALL CASES FIRSTLY CHECK I.T. SYSTEMS FOR RESULTS
Doncaster Royal Infirmary Clinical Biochemistry/Microbiology/Virology/Haematology:
3131 Direct 01302 553131 Fax 01302 553132
About Us
Up to four calls will be queued. Further callers receive a message asking them to ring back Histopathology: Cytology: Morbid Anatomy: Blood Transfusion (Direct) Coagulation (Direct)
3130 / 3782 / 3532 3543 4003 3779 3677
Bassetlaw District General Clinical Biochemistry/Microbiology/Virology/Haematology:
2344 / 2345 Direct 01909 502344 or 01909 502345
Blood Bank: Morbid Anatomy:
Author Title Document No.
Peter J Taylor Pathology Contacts PD-UserHbk-010 ver 1.0
2452 2814
Page 1 of 3 1/4/2008
Directorate of Pathology Contact Telephone Numbers: DEPARTMENT OF CLINICAL LABORATORY SCIENCES Clinical Biochemistry Dr J. Wardell
Consultant Biochemist Director of Pathology
Secretary to Dr. Wardell Dr S. Spoors
About Us
DRI
Secretary to Dr. Spoors Dr R. Stott Mr M. Meadham Dr W. Egner Mr A. Price Mr J. Leverton Mr M. Slokan Mr A. Stevens
BDGH
3106 3535 2486
Consultant Biochemist Head of Department Principal Biochemist Principal Biochemist Consultant Immunologist Head BMS BMS 3 BMS 3 BMS 3
2481 4293 4293 0114 2715700 ext 2837/2058 3763 3799 3786 2483
Other Useful Numbers Results and Specimen Enquiry (Direct Lines) Pathology Specimen Reception Day Ward Booking Fax numbers (Internal)
3131 (01302 553131) 3860 3535 01302 553132 (3132)
2344 (01909 502344) 2450 2544 01909 502462 (2462)
Haematology / Blood Transfusion / Coagulation
DRI
BDGH
Dr J. Joseph*
4180
2457
6483 3001 4098
2457
Dr S. Kaul Dr G. Majumdar* Dr B. Paul*
Consultant Haematologist Lead Clinician Consultant Haematologist Consultant Haematologist Consultant Haematologist
*Denotes Radiopage holder
Haematology Secretaries (Direct Line) Mr D. Norcliffe Mr C. Robinson Mrs G. Bell Mr A. Waller
Head BMS BMS 3 BMS 3 BMS 3
Other Useful Numbers Results and Specimen Enquiry (Direct Lines) Pathology Specimen Reception Day Ward Booking Fax numbers (Internal) Blood Transfusion Laboratory (Direct Line) Blood Transfusion Fax Number (Internal)
Author Title Document No.
Peter J Taylor Pathology Contacts PD-UserHbk-010 ver 1.0
4179 (01302 554179) 3002 (01302 553002) 3542 3677 3779
2495 (01909 502495)
2456 3131 (01302 553131) 3860 3535 01302 553209 (3209) 3779 (01302 553779)
2344 (01909 502344) 2450 2544 01909 502462 (2462) 2452 01909 530693
Page 2 of 3 1/4/2008
Directorate of Pathology DEPARTMENT OF HISTOPATHOLOGY Histopathology / Cytology / Morbid Anatomy
DRI
Dr S. Rogers
3531
About Us
Dr G. Kurien Dr M. Muzaffar Dr J. Stone Dr A. Verghese Histology Secretaries (Direct Line) Mrs A. Hall Mrs B. Crossley
Consultant Histopathologist Lead Clinician Consultant Histopathologist Consultant Histopathologist Consultant Histopathologist Consultant Histopathologist BMS 3 Advanced Practitioner
Other Useful Numbers Fax number Morbid Anatomy
BDGH
6353 6016 4210 6354 3130, 3782, 3532, 4048 01302 553130 6378 4344 01302 553264 3526
2814
DRI
BDGH
MICROBIOLOGY DEPARTMENT Microbiology / Virology Dr F.A.B. Adeyemi-Doro Dr C.M. Hoy Dr A. Brown Dr L.A. Jewes Microbiology Secretaries Mr P. Gravill Bacteriology Laboratory Virology Laboratory Fax number
Consultant Microbiologist Lead Clinician Consultant Microbiologist Consultant Microbiologist Consultant Microbiologist BMS 4
GENERAL PATHOLOGY Miss. S. Bayliss Mr P. Taylor Mrs F. Dunn Mrs H. Chapman
2490 3717 (pager 07659 528215) 6041 (pager 07659 521138) 4017 (pager 07659 500329) 3540 2480 3530 3834 2488 2492 01302 381338 01909 502462 DRI
Pathology General Manager Pathology IT Systems Manager Pathology Quality Manager Pathology Point of Care Co-ordinator
01302 381169 (6169) 01302 381449 (6449) 01302 381473 (6473) 6115
External Links Lab Tests On-line
http://www.labtestsonline.org.uk/
Labs are Vital
http://www.labsarevital.co.uk/
Specimencare
http://www.specimencare.com/
Health Protection Agency
http://www.hpa.org.uk/
Author Title Document No.
Peter J Taylor Pathology Contacts PD-UserHbk-010 ver 1.0
Page 3 of 3 1/4/2008
Directorate of Pathology
Pathology Quality Policy The Pathology Directorate is committed to providing an analytical, interpretative and advisory service of the highest quality and shall be aware and take into consideration the needs and requirements of its users.
About Us
In order to ensure that the needs and requirements of users are met, the Pathology Directorate will: •
operate a quality management system to integrate the Directorate procedures, processes and resources
•
set quality objectives and plans in order to implement this quality policy
•
ensure that all personnel are familiar with this quality policy to ensure user satisfaction
•
ensure that personnel are familiar with the contents of the quality manual and all procedures relevant to their work
•
commit to the health, safety and welfare of all its staff. Visitors to the department will be treated with respect and due consideration will be given to their safety while on site
•
uphold professional values and be committed to good professional practice and conduct
The Pathology Directorate will comply with standards and guidelines set by Clinical Pathology Accreditation (UK) Ltd (CPA), Medicines and Healthcare products Regulatory Agency (MHRA), and the Human Tissue Authority (HTA) and with relevant environmental legislation. The Directorate is committed to: •
staff recruitment, training, development and retention at all levels to provide a full and effective service to its users
•
the proper procurement and maintenance of such equipment and other resources as are needed for the provision of the service
•
the collection, transport and handling of all specimens in such a way as to ensure the correct performance of laboratory examinations
•
the use of examination procedures that will ensure the quality of all tests performed meets user requirements
•
reporting results of examinations in ways which are timely, confidential, accurate and clinically useful
•
evaluation of all processes within the Directorate to ensure continued quality improvement through internal audit, external quality assurance and assessment of user satisfaction.
Signed on behalf of the Directorate of Pathology
……Dr Jean Wardell……………………………………………………
Author Title Document No.
Fiona Dunn Directorate Quality Policy QM-COM-002 v4
Date ……10/7/2007………..
Page 1 of 1 10/7/2007
Departments
Departments
Phlebotomy Point of Care
This section contains information about the individual laboratory departments and specific protocols for their use.
Directorate of Pathology PHLEBOTOMY SERVICE - BASSETLAW In Patient Service A mornings only phlebotomy service is available to the wards at Bassetlaw DGH seven days per week. (Limited weekend & public holiday service). Monday to Friday Each ward will be visited by a member of the phlebotomy team who will take the request forms & bleed patients as required provided that they are wearing appropriate wristbands. On no account will the phlebotomist return to a ward that day. Saturday, Sunday and Public Holidays A reduced number of staff cover this time and requests should be kept to a minimum i.e. those tests that are necessary for immediate patient management only. The forms should be available from 07:00 & the phlebotomist WILL NOT return to any area after the initial visit.
Departments
Please note that National Guidelines will be followed in that any patient not wearing the appropriate wristband will not be bled.
Out Patient Service A phlebotomy service is provided in the outpatient department at Bassetlaw DGH five days per week. This service is for the venepuncture of outpatient clinic and General Practitioner patients. Additionally a service is provided in Newgate Medical Centre four mornings per week, with a peripatetic service around the surgeries of Creswell, Whitwell and Langwith. The opening times for the Bassetlaw site are 08:30 to 16:30 with Newgate Medical Centre open from 08:30 to 12:15 Monday to Thursday. It is not generally necessary to make an appointment for blood tests, the exception being for Glucose Tolerance Tests. For certain investigations (ESR for example) the patient must attend before 16:00
PHLEBOTOMY SERVICE - DONCASTER In Patient Service A mornings only phlebotomy service is available to the wards at Doncaster seven days per week. (Limited weekend and public holiday service) Monday to Friday Each ward will be visited by a member of the phlebotomy team who will take the request forms and bleed patients as required provided that they are wearing appropriate wristbands. On no account will the phlebotomist return to a ward that day Saturday, Sunday and Public Holidays A reduced number of staff covers this time and requests should be kept to a minimum i.e. those tests that are necessary for immediate patient management only. The forms should be available from 07:00 and the phlebotomist WILL NOT return to any area after the initial visit. Author Title Document No.
Peter J Taylor Phlebotomy PD-UserHbk-011 ver 1.0
Page 1 of 2 1/4/2008
Please note that National Guidelines will be followed in that any patient not wearing the appropriate wristband will not be bled.
Out Patient Service A phlebotomy service is provided in the outpatient department at Doncaster five days per week. This service is for the venepuncture of outpatient clinic and General Practitioner patients. The opening times for the Doncaster site are 08:30 to 16:30 It is not generally necessary to make an appointment for blood tests, the exception being for Glucose Tolerance Tests.
Departments
For certain investigations (ESR for example) the patient must attend before 16:00
Author Title Document No.
Peter J Taylor Phlebotomy PD-UserHbk-011 ver 1.0
Page 2 of 2 15/05/2007
Directorate of Pathology Standard Operating Procedure Pathology
Point Of Care Testing Overview SOP No. : SOP-BIO-POCT-001 Date of Issue:
26/09/2005
Page 1 of 4
POINT OF CARE TESTING OVERVIEW
Departments
Version Date of Issue Review Interval Author Authorised By Copy Number Location of Copies
Review date
2.0 26/09/2005 2 years Dr Jean Wardell Dr Shirley Spoors 1 of 3 1 Quality Manager 2 Clinical Biochemistry BDGH 3 Clinical Biochemistry DRI
Document Review History Reviewed by
26.09.05 Updated to combine BDGH/DRI
Filename
Cross Reference Documentation Document Title
CORP/RISK 8 v.1
Author Title
Dr Jean Wardell
Dr Jean Wardell Point Of Care Testing Overview
Policy and Guidelines for Point of Care Testing
Page 1 of 4
Pathology
Point Of Care Testing Overview SOP-BIO-POCT-001 Date of Issue:
26/09/2005
Page 2 of 4
Introduction Point of care testing (POCT) is defined as any form of diagnostic testing undertaken outside of an accredited laboratory environment. POCT is increasingly used as a means of providing immediate results of diagnostic tests in the ward, clinic or surgery to enable therapeutic action to be taken at the time of the consultation. The repertoire of available tests is ever expanding and examples of tests currently marketed are full blood count and haemoglobin, urea and electrolytes, blood gases, blood glucose, urine testing with multistix, pregnancy tests and cholesterol.
Trust POCT Committee The Trust established a multidisciplinary Governance Committee in September 2003. The committee has appropriate representation from throughout the Trust and primary care and is chaired by Dr Jean Wardell, Consultant Biochemist and Clinical Director for Pathology. All decisions relating to point of care testing are made via the Trust Point of Care Testing Governance Committee and all equipment is purchased, maintained and operated following the Trust Policy and Guidelines for Point of Care Testing (CORP/RISK8). This policy includes the Terms of Reference for the Trust POCT Governance Committee.
Departments
POCT within Doncaster and Bassetlaw NHS Foundation Trust The Trust Point of Care Governance Committee has undertaken a review of the point of care testing currently undertaken within the Trust and has concluded that only in specific, well defined sites and circumstances is point of care testing likely to be both reliable and cost effective. In all cases the point of care testing must be introduced and performed in conjunction with the Directorate of Pathology. POCT equipment and tests currently in use within the Trust and under the remit of Pathology are: Location Bassetlaw ICU
Equipment
Analytes
GEM Premier 300 Blood gas analyser
blood gases, electrolytes, glucose lactate, haematocrit, co-oximetry
Labour Ward
Bayer Rapidlab 840 Blood gas analyser
blood gases
Hospital Wide
Advantage glucose meters
glucose
GEM Premier 300 Blood gas analyser
blood gases, electrolytes, glucose lactate, haematocrit, co-oximetry
SCBU
AVL Omni 4
blood gases
Hospital Wide
Advantage glucose meters
glucose
GEM Premier 300 Blood gas analyser
blood gases, electrolytes, glucose lactate, haematocrit
Advantage glucose meters
glucose
Doncaster ICU
Mexborough Phlebotomy
Hospital Wide
Author Title
Dr Jean Wardell Point Of Care Testing Overview
Page 2 of 4
Pathology
Point Of Care Testing Overview SOP-BIO-POCT-001 Date of Issue:
26/09/2005
Page 3 of 4
Responsibilities Two BMS 2s in the Clinical Biochemistry Department have designated responsibilities for POCT; one based at Bassetlaw and one based at Doncaster. They are responsible for overseeing the POCT blood gas analysis: • Training of staff • Maintenance of equipment and reagents • Ordering of consumables • Health and Safety requirements • Quality control and quality assurance The Bassetlaw based BMS 2 and a Principal Clinical Scientist based at Doncaster are responsible for the organisation of external quality assurance of the ward based glucose meters at each site. Training is undertaken by the supplier.
Right to Use Equipment
Departments
This is restricted to the designated individuals who have been trained by laboratory staff or the manufacturer. It is the users responsibility to ensure that the correct sample is analysed in the correct manner.
Training of Staff The blood gas and electrolyte equipment is operated by medical staff and nursing staff by agreement, after appropriate training. No personnel, neither medical nor nursing, are permitted to use the equipment without prior training by laboratory staff. Approved training protocols are available for all appropriate staff and training is carried out by qualified laboratory staff only. Records are kept of those personnel who have been trained and are authorised to use the equipment. Trained staff are encouraged to update their training regularly. Blood glucose meters are used by nursing staff throughout the Trust who are trained and regularly updated by the meter providers (Roche) via Trust training sessions organised by Roche. Training records are maintained.
Health and Safety Requirements The blood gas analysers are sited in special rooms used only for laboratory purposes. The laboratory safety code of practice applies at these sites and for all other point of care testing equipment. Safety standards, including decontamination procedures etc, are discussed at training. Ward staff are ultimately responsible for safety standards of point of care testing equipment sited on wards. Individual staff who carry out tests are responsible for complying with national and local safety standards.
Maintenance of Equipment and Reagents Laboratory staff are responsible for maintenance of the blood gas analysers in accordance with the manufacturers instructions and will contact the manufacturer should the need arise. Laboratory staff are responsible for relevant stock control. Decontamination and servicing of the Roche glucose meters is undertaken by ward staff who have been trained by the meter suppliers (Roche).
Quality Control and Quality Assurance This is an integral part of any laboratory analysis and provides independent scrutiny of the quality of results. For the blood gas analysers laboratory staff check the internal quality control at the time of any daily maintenance and calibration of the equipment and organise participation in an External Quality Assurance
Author Title
Dr Jean Wardell Point Of Care Testing Overview
Page 3 of 4
Pathology
Point Of Care Testing Overview SOP-BIO-POCT-001 Date of Issue:
26/09/2005
Page 4 of 4
scheme. Laboratory staff monitor performance and will discuss any problems as they arise. This will be discussed during training. Quality Control solutions for the Roche glucose meters are supplied by Roche and distributed to the users via the Clinical Biochemistry Department who also retain the results. The solutions are analysed routinely by the users. The external quality assurance scheme for glucose meters is organised by the Clinical Biochemistry Department and available for all Trust meters and all compatible devices in use in the community e.g. GP practices, midwives.
Reporting of Results There is a legal requirement to ensure that all results are properly recorded.
Departments
All results from the blood gas analysers must be filed or recorded in the patient notes. It is the responsibility of the ward staff to ensure this is done.
Author Title
Dr Jean Wardell Point Of Care Testing Overview
Page 4 of 4
Directorate of Pathology Standard Operating Procedure Pathology
Point Of Care Testing Guidelines For Users SOP No. : SOP-BIO-POCT-002 Date of Issue:
26/09/2005
Page 1 of 6
POINT OF CARE TESTING GUIDELINES FOR USERS
Departments
Version Date of Issue Review Interval Author Authorised By Copy Number Location of Copies
Review date
2.0 26/09/2005 2 years Dr Jean Wardell Dr Shirley Spoors 1 of 9 1 Quality Manager 2 Clinical Biochemistry BDGH 3 Clinical Biochemistry DRI 4 Intensive Care Unit BDGH 5 Intensive Care Unit DRI 6 Special Care Baby Unit DRI 7 Labour Ward BDGH 8 Mexborough Phlebotomy Area 9 All sites of ward based glucose meters via intranet Document Review History Reviewed by
26.09.05 Updated to combine BDGH/DRI
Filename
Cross Reference Documentation Document Title
CORP/RISK 8 v.1
Author Title
Dr Jean Wardell
Dr Jean Wardell Point of Care Testing Guidelines for Users
Policy and Guidelines for Point of Care Testing
Page 1 of 6
Pathology
Point Of Care Testing Guidelines For Users SOP-BIO-POCT-002 Date of Issue:
26/09/2005
Page 2 of 6
INTRODUCTION Point of care testing (POCT) is defined as any form of diagnostic testing undertaken outside of an accredited laboratory environment. There are increasing expressions of interest in the use of POCT equipment outside the laboratory, particularly by general practitioners. The use of POCT equipment within the Trust is currently limited to blood gas analysis on specific wards, glucose analysis throughout the hospital and the use of urine dip stix and pregnancy tests. It is recommended that the need for POCT is always discussed with the relevant pathology laboratory in the first instance. Should the need be identified, then the laboratory will enter into the discussions about aspects which must be covered and ways in which the laboratory can help. All decisions relating to point of care testing must then be made via the Trust Point of Care Testing Governance Committee and all equipment is purchased, maintained and operated following the Trust Policy and Guidelines for Point of Care Testing (CORP/RISK8).
Departments
The Directorate of Pathology has overall responsibility for the point of care use of the blood gas analysers and glucose meters. Currently under discussion within the Trust POCT Governance Committee is bringing the use of urine dip stix and pregnancy tests under the same governance umbrella and a further expansion of POCT at specified sites throughout the Trust. An on-going remit of the committee is to identify additional POCT equipment that may already be in use but without any input from Pathology.
GENERAL ASPECTS OF POCT TESTING WHICH MUST BE CONSIDERED Main Purposes of Point of Care Testing 1.
Produce a result more quickly in order to enable more effective counselling of the patient and/or change in therapeutic management.
2.
Reduce the total attendance time for the patient.
3.
Reduce the patient journey.
Points to Consider before Introduction of POCT •
What test(s) are required and how many? - POCT devices do not generally handle large numbers of samples efficiently
•
Which patients need the test and what is an acceptable analysis time for them?
•
Why is the test required POCT - what is the problem with the current service?
•
Is there suitable equipment available for POCT use?
•
What is the technical performance of the device to be used - will POCT provide the same level of accuracy and precision as the current service?
•
Will the result delivered by POCT be accessible to an electronic patient record with a full audit trail of quality i.e. user ID, patient ID and quality control?
•
Can adequate guidelines be introduced for dealing with the interpretation of results, particularly those that are abnormal or unexpected?
•
Are there suitable staff available to perform and interpret the test?
•
Is POCT acceptable to all staff and patients?
•
Are there adequate facilities available to perform POCT?
•
Are there adequate facilities for disposal of samples and consumables?
•
What is the cost of POCT compared to the current service?
Author Title
Dr Jean Wardell Point Of Care Testing Guidelines For Users
Page 2 of 6
Pathology
Point Of Care Testing Guidelines For Users SOP-BIO-POCT-002 Date of Issue:
26/09/2005
•
What are the clinical benefits of POCT?
•
Will POCT improve patient outcomes and/or decrease patient journeys?
•
Page 3 of 6
There is an absolute requirement to follow the Trust Policy and Guidelines for Point of Care Testing (CORP/RISK8) for all tests performed outside the accredited laboratory, as failure to conform may lead to claims of negligence.
Choosing the POCT Equipment
Departments
The advice of the relevant laboratory must always be sought before any equipment is considered and approval of the Trust Point of Care Governance Committee gained before any equipment is purchased. The Trust Policy and Guidelines for Point of Care Testing (CORP/RISK8) must be adhered to ensure: •
Results are comparable to results produced by the laboratory
•
Reliability of equipment and spares
•
Good cover by service engineers
•
Reliability and regular supply of reagents
•
Avoidance of multiple suppliers of similar equipment
•
All clinical, economic and practical aspects are covered adequately in the business case
•
Connectivity requirements are met wherever possible
•
Adherence to protocols established by the Trusts Supplies Department
Use of POCT The Directorate of Pathology cannot be responsible for poor analytical performance, provided that the analyst has been adequately trained, equipment has been properly maintained, and quality control has been properly supervised. These aspects will be the responsibility of the laboratory Training All users must be adequately trained in accordance with manufacturers' specifications and their training recorded. It is an absolute requirement that only those who are thoroughly familiar with the equipment, and trained in its use, can use it. Other users should only use equipment under close supervision until considered competent to do so. All trained users must periodically update their own training. Health and Safety Safety in use of equipment must always be demonstrated. Safe handling of blood samples requires adherence to a strict code of practice. Maintenance and Stock Control Product liability requires records of all reagents used (batch numbers and date of delivery) must be maintained. The manufacturers' instructions for maintenance must be adhered to and there is a need to be able to demonstrate that instructions or warnings in relation to use and maintenance are observed and passed on to all users. Quality Assurance and Quality Control Quality procedures will ensure accuracy of the patient results. Internal quality control and appropriate external quality assessment programmes must be adhered to, and subject to inspection. All internal quality control and external quality assurance data must be adequately recorded and the records accessible to inspection. This may be the responsibility of the laboratory or devolved to the users under supervision form the laboratory. Reporting of Results All reports must be correctly labelled and filed in the patient notes, and ultimately in the electronic patient record. It is essential to identify who is responsible for the results produced. This cannot be the responsibility of the main laboratory. Author Title
Dr Jean Wardell Point Of Care Testing Guidelines For Users
Page 3 of 6
Pathology
Point Of Care Testing Guidelines For Users SOP-BIO-POCT-002 Date of Issue:
26/09/2005
Page 4 of 6
BLOOD GAS ANALYSERS Blood gas analysis is currently available on ITU at BDGH and DRI, SCBU at DRI, Labour Ward at BDGH and in the Phlebotomy area at Mexborough Hospital.
Who may use the Blood Gas Analysers Medical and nursing staff who have been adequately trained by the Clinical Biochemistry laboratory. A register of all trained users is maintained by the laboratory. Aspects covered during training include quality control, sources of errors likely to be encountered, use of equipment (principles involved), health and safety, documentation of results, dealing with high risk samples and procedures for decontamination. Also considered are demonstrations of the consequence of improper use of equipment and limitations of equipment in use.
Responsibility of Users Medical staff are responsible for interpretation of results and for any action taken upon them. It is the responsibility of the users to ensure that the correct sample is used, that the results are documented in the patient notes and that the equipment is kept clean and tidy.
Departments
Role of Clinical Biochemistry Laboratory • • • • • • •
Train all users of the equipment and maintain a register of trained users Maintain up to date standing operating procedures Undertake appropriate routine equipment maintenance and maintain records Liaise with equipment service engineers Maintain adequate stocks of reagents and consumables Oversee internal quality control Organise participation in an external quality assurance scheme
Standard Operating Procedures These are available next to each blood gas analyser. Additional information is available in the manufactures operating instructions also located next to the analysers.
Health and Safety Laboratory safety codes will be discussed with all users as outlined in the Training Manual. It is the responsibility of the users to maintain the equipment and working area clean and tidy in accordance with Trust Health and Safety policy.
Maintenance and Stock Control The Clinical Biochemistry laboratory will maintain the equipment in good working order. The laboratory will maintain service records and in the event of a major breakdown, will be responsible for calling the service engineers. Laboratory staff will be responsible for purchasing the necessary reagents and consumable and their correct storage and shelf life and will ensure that adequate stocks of consumables are always available, in conjunction with ward staff where appropriate.
Quality Control and Quality Assurance Quality control procedures will be agreed by all users. The laboratory will be responsible for the internal quality control and external quality assurance programmes and will continuously monitor equipment performance. Internal quality control checks will be checked regularly by laboratory staff to ensure that equipment is working within predefined limits. Any remedial action needed as a result of poor quality control or assurance will be discussed with the users and remedial action will be instituted by laboratory staff.
Author Title
Dr Jean Wardell Point Of Care Testing Guidelines For Users
Page 4 of 6
Pathology
Point Of Care Testing Guidelines For Users SOP-BIO-POCT-002 Date of Issue:
26/09/2005
Page 5 of 6
GLUCOSE METERS Glucose meters have been introduced into all wards and departments across the Trust. Their use for monitoring blood glucose is recommended in preference to visual reading of BM sticks. Availability of meters does not alter the provision of laboratory testing in any way.
Advantages New meters are capable of giving reliable and rapid results provided the testing protocol is strictly adhered to and limitations of the method are fully appreciated.
Departments
Limitations and Contraindications 1.
Laboratory results should be the basis of appropriate treatment.
2.
Any sample reading less than 3mmol/L or above 20mmol/L must be verified by sending venous blood to the laboratory for random blood glucose.
3.
Any patient being monitored at frequent intervals each day must have venous blood checked daily by the laboratory.
4.
Results are unreliable in severe jaundice (bilirubin > 340µmol/l), in severe dehydration including DKA and HONK and at extremes of haematocrit (neonates). Refer to training manual for further details. Under these circumstances bloods should be sent to the laboratory for analysis.
Who may use the Glucose Meters All grades of nursing staff may use meters for patient testing provided that they have been trained by the identified Diabetic Link Nurse in each ward, or by the Diabetic Liaison Nurse. In addition, laboratory staff and representatives from the company will assist in staff training. The Diabetic Liaison and Link Nurses are trained by the supplier. The Liaison Nurse will keep a register of Link Nurses. All trained users will be given a certificate when they have been trained.
Role of the Diabetic Liaison Nurse • • •
Training and certification Monitoring internal quality control and external quality assurance in conjunction with the Clinical Biochemistry department Source of expert advice for trained users
.
Responsibilities of Diabetic Link Nurses • • • • • • • • •
Author Title
Training, certification and retraining of all users in their area Maintenance of meters, including regular cleaning Health and safety aspects of use of meters and blood testing Internal quality control - oversee its regular and correct performance External quality assurance – ensure samples distributed by Clinical Biochemistry are analysed and the results returned promptly Stock control (spare batteries and spare meters are available from the Diabetic Liaison Nurse or from Clinical Biochemistry) Documentation of maintenance, QC and patient results Security of meter Liaison with Diabetic Liaison Nurses and laboratory
Dr Jean Wardell Point Of Care Testing Guidelines For Users
Page 5 of 6
Pathology
Point Of Care Testing Guidelines For Users SOP-BIO-POCT-002 Date of Issue:
26/09/2005
Page 6 of 6
Responsibility of Users Medical Staff are responsible for interpretation of results and for action taken upon any glucose result. It is the responsibility of the users to ensure that all results are recorded in the patient notes and to maintain the meters in a clean condition.
Role of Clinical Biochemistry Laboratory • • •
Assist the Diabetic Liaison Nurse as required in staff training, troubleshooting poor meter performance, meter maintenance and improving quality of testing Maintain up to date standard operating procedures Organise an external quality control scheme on behalf of the Diabetic Liaison Nurse and assist in monitoring performance of testing throughout the hospital
Standard Operating Procedures These are available in all wards and departments. The Roche ‘Blood Glucose Monitoring Standard Instruction Manual’ is also available in all wards and departments. Additional information is available from Diabetic Liaison Nurse.
Departments
Health and Safety Health and safety codes will be discussed at training. It is the responsibility of the users to maintain the meters and working area clean and tidy in accordance with Trust Health and Safety policy.
Quality Control and Quality Assurance Quality control procedures will be agreed by all users. The users will be responsible for the internal quality control programme, for documenting the results and for ensuring that the meters are not used if the quality control is outside predefined limits. The Clinical Biochemistry laboratory will organise an external quality assurance programmes and will continuously monitor equipment performance using the data. Any remedial action needed as a result of poor quality control or assurance will be discussed with the users and remedial action will be instituted by laboratory staff.
Arrangements for Replacement of Meter Should replacement be needed contact Diabetic Liaison Nurse, or Clinical Biochemistry. Any users considering alternative equipment should discuss their choice with the laboratory and Diabetic Liaison Nurse. This will ensure uniformity of results, training etc throughout the Trust.
Author Title
Dr Jean Wardell Point Of Care Testing Guidelines For Users
Page 6 of 6
Requesting
Requesting
Making a request Labelling Transport
This section contains information about the requesting of laboratory tests how they are to be labelled and transported to the laboratory.
Directorate of Pathology
POLICY FOR SPECIMEN AND REQUEST FORM LABELLING
Requesting
Summary of changes: • Alteration to minimum data sets for identification of specimen details (no change to minimum data sets for request form) • Histopathology sample containers should be handwritten • Pre-printed addressograph labels are NOT acceptable on sample containers (except for samples labelled according to safe patient identification procedures and pre-approved by Pathology). • Labels printed contemporaneously, i.e. beside patient and at the time that the sample is being taken, will be accepted on sample containers if they include the minimum sample data set and are initialled by the person taking the sample to confirm that they have verified identification with the patient. • Clarification that samples will not be analysed if additional essential information is incomplete
Written by: Date: Approved by: Date: minutes) Implementation Date:
Andrew Cross March 2003 Clinical Review Group v.1 - April 2003, v.2 - January 2006, v.3 - 1/6/2007 (see
Reviewed by: Date:
Dr Wardell – Clinical Director Pathology - Consultant Clinical Biochemist July 2005, February 2007
For Review:
February 2009
v.1 - June 2003, v.2 - February 2006, v.3 - March 2007
WARNING: Always ensure that you are using the most up to date policy or procedure document. If you are unsure, you can check that it is the most up to date version by looking on the Trust Website: www.dbh.nhs.uk under the headings ‘Freedom of Information’‘Information Classes’-‘Policies and Procedures’
Author Dr J Wardell Title Policy for Specimen and Request Form Labelling Document No. PAT/T8 v.3
1
REF: PAT/T 8 v.3 Introduction This policy ensures adequate identification criteria for Pathology specimens and request forms in order for them to be accepted by the laboratory for analysis. It is the requestor’s responsibility to ensure that all details are correct, clearly written and that the specimen details match those on the form. Inadequately or inaccurately labelled specimens or forms will not be accepted unless they are considered to be ‘unrepeatable’. A classification of ‘unrepeatable’ will be on an individual basis and in these cases the requestor may be required to come to the laboratory to amend their request information and to document that they have done so. Any labelling discrepancy will be included on the pathology report. Inadequate or inaccurate labelling results in delays before pathology results are available and hence affects patient care. Request Form Minimum Data Set for Identification: • PAS and/or NHS number (A/E or District Number if patient not registered) • Patient Surname and Forename (in full, not initials) • Date of birth • Patient address if PAS/NHS number not supplied
Requesting
In addition to the minimum data set for patient identification please ensure all other relevant fields are completed: • Ward/ Practice, Consultant/GP • Patient address • Patient gender • Date and time of collection • Specimen type • Investigation(s) required • Name of requesting clinician and bleep number • Relevant clinical details • Current drug therapy • Copy reports, if required • Patient category (PP/ CAT 2 / NHS) Specimen Details Minimum Data Set for Identification: • Patient’s Surname • Patient’s Forename (Initial is acceptable unless it is a blood transfusion sample, but full name is preferable) • Date of Birth and/or PAS/NHS/AE number (both required for Blood Bank samples) • Date and Time of collection Please Note:
Author Dr J Wardell Title Policy for Specimen and Request Form Labelling Document No. PAT/T8 v.3
2
REF: PAT/T 8 v.3 • Pre-printed addressograph labels are NOT acceptable on sample containers (except for samples labelled according to safe patient identification procedures and pre-approved by Pathology). This includes histopathology samples. • Labels printed contemporaneously, i.e. beside patient and at the time that the sample is being taken, will be accepted on sample tubes if they include the minimum data set and are initialled by the person taking the sample to confirm that they have verified identification with the patient. (It is important that the size and thickness of labels placed on samples does not cause difficulties with sample testing. Therefore please seek guidance from the relevant department before using labels). • Addressograph labels are acceptable on request forms. • Ensure all copies of request form are labelled with addressograph labels • Always include Danger of Infection stickers for high risk patients • Request form and sample details must correspond In addition to the minimum data sets for identification, samples will not be analysed if other essential information is incomplete. Please see additional department specific details for information.
Requesting
ADDITIONAL DEPARTMENT SPECIFIC DETAILS:Blood Transfusion and Blood Grouping Requests • Person taking blood must sign specimen and request form • Request form must be signed by requesting Doctor • Latest Hb result and reason for transfusion, number of units required, time and date required, special requirements e.g. CMV negative or irradiated products required should be indicated on the form. • Please refer to Hospital Blood Transfusion policy PAT/T2 Clinical Biochemistry • For glucose and lipids, state fasting or non-fasting. • For drug analysis, time of last dose and time of sample collection are required. • For antenatal screening for Down’s syndrome and NTD, gestational age and patient weight must be provided. • For pregnancy tests and female hormones, state LMP or day of cycle • Patient gender must be included for reference ranges to be included on report. Haematology • Patient gender must be included for reference ranges to be included on report.
Microbiology • Include specimen type and site • For antibiotic assay levels e.g. Gentamicin, a ‘Gentamicin sticker’ must be applied to the request form and the following information completed: Mg of last dose given Author Dr J Wardell Title Policy for Specimen and Request Form Labelling Document No. PAT/T8 v.3
3
REF: PAT/T 8 v.3 Date and Time of last dose Date and time that sample was taken (pre and post dose samples required for multiple dosing). Please refer to Gentamicin guidance document. Gentamicin labels are available from Pathology reception. Histopathology • Include specimen type and site on both request form and specimen container • Indicate patient consent / objection to use of surplus tissue for education / QC Cytology • Include LMP
ADDITIONAL INFORMATION Unidentified Patients The request form and samples must contain a unique identifier number which is available on PAS (i.e.District number / Bassetlaw A&E number), and patient gender. All request forms must be signed.
Requesting
GUM Patients Where Patient name is not appropriate, then GUM number, patient gender and DOB will be acceptable
Paediatric Samples/Gas syringes Use labels provided and attach to each sample tube
Health and Safety Affix ‘Danger of Infection’ stickers on samples and request forms from patients with the following conditions • Hepatitis B, Hepatitis C and HIV • Infective or suspected infective diseases of the liver • Known or suspected cases of Mycobacteria (TB) Salmonella typhi / paratyphi (Typhoid / Paratyphoid) E.coli 0157 Dysentery with Shigella dysenteriae Brucellosis • Patients in at-risk groups Inadequate and incorrectly labelled requests and unsuitable samples. The Directorate will make every effort to ensure requests are processed in a safe and timely manner but it is essential that request forms and samples are labelled appropriately and legibly in compliance with this policy. It is also important to clearly identify the investigations required with relevant supporting information.
Author Dr J Wardell Title Policy for Specimen and Request Form Labelling Document No. PAT/T8 v.3
4
REF: PAT/T 8 v.3 If you have any doubts regarding this policy please ring the relevant department for further information.
Requesting
Specimens will not be accepted for analysis if: • There is an incorrect sample type or tube • Incorrect transportation conditions • Sample is received in a hazardous condition e.g. leaking • Sample or request form is unlabelled or incorrectly labelled with less than the minimum data sets for patient identification • Request form does not include all the essential additional information e.g. fully completed gentamicin label • Pre-printed addressograph label used on sample container (with the exception of samples labelled according to safe patient identification procedures and pre-approved by Pathology) • Mismatch of details between the form and sample(s) • The information provided is illegible
Author Dr J Wardell Title Policy for Specimen and Request Form Labelling Document No. PAT/T8 v.3
5
SURNAME FORENAME
SMITH JOHN
Follow the trust policy (PAT/T8) and avoid mistakes by labelling all types of samples correctly with the full name,date of birth and ID number rather than the proven risk of the wrong sticky label Remember Transfusion samples must have all details and be signed
Refer to electronic Pathology Handbook www.dbh.nhs.uk
Sample Labelling Poster - Trust Version - November 2005
Requesting
12/12/1864 TIME1.30PMDATE 5/4/05 WARD X2 NO. 123 456 7890 SIG. Jo Bloggs DOB
General Pathology Request Form
BIOHAZARD
Use this form for Clinical Biochemistry, Haematology, Immunology, Microbiology and Virology
NHS No.
CLINICAL BIOCHEMISTRY HAEMATOLOGY, MICROBIOLOGY
ESR
APTT
Blue
U/E
Gold
PT/INR
Blue
BONE
Gold
LFT
Gold
Lavender
GLU
UNIT No.
Grey SURNAME
D.O.B.
Fasting Random FORENAMES
M/F
OTHER TESTS - Specify PATIENT'S ADDRESS
CLINICAL DETAILS INC. DATE OF ONSET / DRUG THERAPY / TREATMENT
SEND COPY TO
CONSULTANT / GP
SPECIMEN / SITE
WARD / SURGERY
TIME LAST MEAL / DOSE DATE/ TIME SAMPLE TAKEN MICROBIOLOGY / VIROLOGY REQUESTS PLEASE USE INDIVIDUAL FORMS FOR THESE REQUESTS AND A SEPARATE GOLD TOP TUBE FOR SEROLOGY SAMPLES
REQUESTING DOCTOR (BLOCK CAPITALS)
SIGNATURE
BLEEP No.
Has ID on form and all samples been verified with Patient ?
BIOHAZARD
DO NOT ATTACH ADDRESSOGRAPH LABELS TO SAMPLE TUBES
HAVE YOU LABELLED FORM & SAMPLE CORRECTLY ?
CLINICAL BIOCHEMISTRY / HAEMATOLOGY / IMMUNOLOGY REQUESTS FBC
PRIVATE
IF NOT NHS PATIENT PLEASE TICK
Requesting
PLACE SPECIMEN IN BAG
BIOHAZARD
FOLD TOP OVER TO SEAL
CLINICAL BIOCHEMISTRY HAEMATOLOGY, MICROBIOLOGY
February 2006 Check the Pathology Handbook at www.dbh.nhs.uk for updates
BIOHAZARD
HIGH RISK CASES All specimens and request forms from patients known or suspected of having Hepatitis B, Hepatitis C or HIV infection MUST be identified with "DANGER OF INFECTION" labels. Other "high risk" infectious agents which should be notified are listed in the Microbiology section of the Laboratory Handbook. BIOHAZARD
CAT 2
REMOVE COVERING STRIP
URGENT/FAST TRACK > The fast track service is only available from the departments of Clinical ENQUIRIES Biochemistry and Haematology from 09.00 - 17.00 Monday to Friday Can be made to either site regardless of which laboratory sample sent to. > A sample will only be accepted as fast Direct 01302 553131 Doncaster (Internal 3131 or 713131 from BDGH) track if the department receives a Direct 01909 502344 Bassetlaw (Internal 2344 or 752344 from DRI) telephone call BEFORE the sample is received. Blood Tests (Phlebotomy) open 9.00am to 4.30pm- Monday to Friday > Work will be analysed as routine either: if there is no telephone call or if the SAMPLE TUBE GUIDE - Draw Tubes in Order Given sample is already in the laboratory SODIUM CITRATE 1:9 Coagulation Screen, Prothrombin Time (INR), APTT, Thrombophilia Screen, BLUE when the telephone call is received. Lupus Anticoagulant Screen (Fill to line essential) > Processing time is subject to equipment PLAIN (No Additive) Procollagen, Lamotrigine availability, and is timed from when the RED sample arrives at the laboratory. All other Biochemistry Tests (1 Tube), Microbiology (1 Tube), Anti-Cardiolipin antibodies SST GOLD PROTOCOL Chromosome Studies, Lead, Amino Acids, Troponin LIGHT GREEN HEPARIN > Take the sample and complete the EDTA FBC, Reticulocytes, Sickle Screen, Haemoglobinopathy Screen, G6PD, GF Test, Viscosity, LAVENDER appropriate request form. Malarial Parasites, RBC Folate, ZPP, Marker Studies, Lead, Mercury Complement, > Write "FAST TRACK" on the request Glycosylated Haemoglobin, PCR Virology Tests form. EDTA (X-Match) Blood Group, Save Serum, Crossmatch, blood Group Antibodies, Cord Blood Samples PINK > Telephone Pathology reception > (DRI 3860 BDGH 2344) FLUORIDE OXALATE Glucose, Ethanol (Alcohol), Lactate GREY with the following information: SODIUM HEPARIN Copper, Selenium, Zinc DARK BLUE Your name and location Patients name HEALTH AND SAFETY PRECAUTIONS, SPECIMEN HANDLING Test(s) required and the reason for NEVER EAT, DRINK OR SMOKE WHEN TRANSPORTING SPECIMENS & WASH YOUR HANDS FREQUENTLY. the urgent request CARRY ALL SPECIMENS IN THE APPROVED SPECIMEN CONTAINER NOT IN YOUR POCKETS Details of route for result (Phone No. /Bleep No. or on VDU) IF THERE IS A SPECIMEN BREAKAGE AND SPILLAGE, ISOLATE THE AREA TO PREVENT ACCESS AND IF > Send the sample to Pathology reception YOU HAVE AN ACCIDENT INVOLVING CONTAMINATION WITH A SPECIMEN, CONTACT A SENIOR MEMBER via Tube system or Service Assistant OF STAFF IN THE CLINICAL OR LABORATORY AREA.
www.dbh.nhs.uk
YES / NO
M SEX
BIOHAZARD
Blood Bank Group & Save
M/F
Surname
BLOOD BANK
Red Cells Forename FFP*
Cryo*
Platelets*
Novo7*
Beriplex*
*Contact Consultant Haematologist
Patients Address
Number of units / vials required Date & Time required Special Requirements
CMV Negative
Irradiated products
Previous Blood Group
Known Antibodies
Previous Transfusion
Previous Pregnancies
Consultant
Ward
Requesting Doctor
Bleep No.
Private
CAT 2
Sample may be delayed without details in this section Recent Hb Clinical Details
If Applicable give details indicated below: NBS Number Delivery or sensitising event Gestation
Date
Last Anti-D issue:
Date
Time Dose
Date / Time
Sample taken by Signature of Medical Officer
www.dbh.nhs.uk BIOHAZARD
ENQUIRIES Doncaster Extension 3779 Bassetlaw Extension 2452 IMPORTANT - Please read carefully before sample collection Addressograph labels must NOT be used on the sample All requests for blood products MUST be signed by a Medical Officer
To avoid the risks associated with transfusion please consider the use of alternatives. (Iron, Folate, B12 Erythropoetin etc.) Routine 'Top-Up' transfusions are processed during the normal working day and not 'Out of hours'. Advice is available from Blood Bank, the Hospital Transfusion Practitioner or the Consultant Haematologist as appropriate. This section is for laboratory use only Antibody Screen
Group of Baby
Kleihauer
DCT
Batch No.
Expiry
Issue of prophylactic Anti-D
Dose
February 2006 - Check the Pathology Handbook at www.dbh.nhs.uk for updates
BIOHAZARD
Group of Patient
FOLD TOP OVER TO SEAL
BLOOD BANK
All incorrect, illegible or incomplete requests (sample or form) will be discarded (Please see the Trust's Blood Transfusion Policy and Sample labelling policy)
PLACE SPECIMEN IN BAG
REMOVE COVERING STRIP
Blood Bank
Requesting
D.O.B.
NHS No.
BLOOD PRODUCT REQUIREMENTS
BIOHAZARD
NO.
Unit No.
Direct Coombs
Kleihauer
SMITH JOHN
WARD
SURNAME FORENAME
HAVE YOU LABELLED
FORM & SAMPLE CORRECTLY ? DO NOT ATTACH ADDRESSOGRAPH LABELS TO SAMPLE TUBES
DO NOT USE TRANSPORT TUBE SYSTEM
DOB 12/12/1864 TIME1.30PMDATE 5/4/05 X2 SIG. Jo Bloggs 123 456 7890
Blood Bank Request Form
c
BD Vacutainer System 速
BD Diagnostics - Preanalytical Systems
Tube Guide including Order of Draw Please display this in your clinical areas beside your venepuncture equipment
Doncaster and Bassetlaw Hospitals NHS Foundation Trust - Printed 0807 Blood samples should be taken in the following order:
Catalogue Number
Colour Code
KFK186 Draw Volume
4.5ml
5ml
4ml
Aerobic followed by anaerobic. If insufficient blood for both culture bottles, use aerobic bottle only.
Sodium Citrate
Coagulation Screen, PT (INR), APTT, Thrombophilia Screen, Lupus Anticoagulant Screen
Sample MUST be filled to the mark
Black
3.5ml
4ml
4ml
SST II
All Biochemistry tests not mentioned elsewhere (1 tube), Microbiology (1 tube), Immunology tests
Mixing guidelines: 5 - 6 times
Heparin & PST II
Chromosome Studies, Amino Acids, Troponin, Synovial fluids for crystals
Mixing guidelines: 8 - 10 times
Mixing guidelines: 5 - 6 times
TM
EDTA Lavender
KFK277 Draw Volume
6ml
Pink
KFK250 Draw Volume
4ml
Grey
KFK235 Draw Volume
7ml
Samples for anticonvulsants should be taken before the dose is given
Green
KFK171 Draw Volume
Mixing guidelines: 8 - 10 times
Procollagen, Lamotrigine
Gold
KFK281 Draw Volume
Mixing guidelines: 3 - 4 times
Serum
TM
Draw Volume
ESR at Bassetlaw Only. At Doncaster Royal Infirmary use lavender Tube (EDTA)
Red
KFK112
Special Instructions
Culture of micro organisms from blood
ESR
KFK242 Draw Volume
Determinations
Blood Culture
Light Blue
KFK013 Draw Volume
Tube Type
Cross Match
FBC, Sickle Screen, Haemoglobinopathy Screen, G6PD, Glandular Fever Screen, Malarial Parasites, ZPP, RBC Folate, Cell Marker Mixing guidelines: 8 - 10 times Studies, Lead, Complement, HbA1c, PCR, Viral Loads, HLA B27, Kleihauer Blood Group and antibodies, Crossmatch, Cord Blood samples
Mixing guidelines: 8 - 10 times
Fluoride Oxalate
Glucose, Ethanol (Alcohol), Lactate
Mixing guidelines: 8 - 10 times
Trace Element
Copper, Selenium, Zinc
Mixing guidelines: 8 - 10 times
Royal Blue
*RECOMMENDED ORDER OF DRAW: 1. Blood culture bottles 2. COAGULATION Tubes 3. Tubes with no Additives 4. OTHER Tubes with ADDITIVES
For further copies of this guide and questions regarding specific tests, please contact the main Pathology Laboratory. BD, BD Logo, Vacutainer and Hemogard are all trademarks of Becton, Dickinson & Company. *Clinical and Laboratory Standards Institute Guidelines H3-A5 Vol 23 No. 32, 5th Edition BD Diagnostics - Preanalytical Systems, Tel: 01865 781603
BD Vacutainer System ®
BD Diagnostics, Preanalytical Systems
Mixing Guidelines All BD Vacutainer tubes require immediate mixing following collection ®
Colour Code
Tube Type
Inversions
Serum
5-6 Times
Sodium Citrate
3-4 Times
Sodium Citrate ESR
8-10 Times
SST II
5-6 Times
Red
Light Blue
Black TM
Gold
Heparin & PST II
8-10 Times
EDTA
8-10 Times
Cross Match
8-10 Times
Fluoride Oxalate
8-10 Times
Trace Element
8-10 Times
TM
Green
Lavender
Pink
Grey
Royal Blue
Insufficient mixing can result in inaccurate test results and the need to re-draw
Directorate of Pathology
Blood Cultures Procedure for collection and inoculation of bottles It is important that when taking blood cultures the following procedure is followed, this is to ensure the best recovery of significant micro-organisms and to minimise contamination from skin flora. Blood cultures may be taken using either a syringe and needle or a butterfly system. For an adult set use a blue and purple set of bottles and inoculate each bottle with 10mls and for paediatric samples use a yellow bottle and add up to 4mls. Blood culture should be taken from a venepuncture site specifically for this purpose. If a culture is being collected from a central venous catheter, disinfect the access port with alcohol swab. When blood is being collected for other tests, always inoculate blood culture bottles first. •
Before starting, wash your hands with soap and water, dry and apply clean examination gloves. Ensure that all necessary items are available:- tourniquet, syringe, needles/butterfly, vacutainer adapter caps/inserts, 3 alcohol swabs, Sterile gauze swabs, Hypoallergenic tape, Request form and blood culture bottles (1 aerobic, blue and 1 anaerobic, purple for a normal set).
•
Stand bottles on a fixed, hard surface. Remove the protective coloured plastic covers from the caps of the blood culture bottles and wipe the rubber seals with a fresh alcohol swab and allow to dry for 30 seconds.
•
Apply tourniquet, find target vein and wipe the area thoroughly for 30 seconds with alcohol swab, leave to dry for 30 seconds. Do not palpate again after cleaning.
Butterfly system
Requesting
• Attach butterfly to adapter cap (1,2) •
Perform venepuncture. When the needle is in the vein, secure it with tape or hold it in place. (3,4)
•
With the bottles on a level surface place the cap over the bottle neck of the first blood culture bottle (blue) Allow blood to flow until an increase in volume of approximately 10mls is achieved. Transfer the cap to the other bottle (purple) and repeat. (4,5)
• Write patient details and if appropriate the site of sampling onto each bottle.
1
2
3
4
5
• If additional blood is required for other tests, place the Adapter Insert into the Adapter Cap and snap into place. This makes the cap compatible with vacuum collection tubes. (6,7)
6
7
Syringe and needle •
When using a syringe and needle draw 20mls and ensure 10mls of blood is added to each bottle, inoculating the purple bottle first followed by the blue. Do not add more than 10mls to each bottle.
•
Do not reduce the volume of blood for cultures (unless difficulty in obtaining sample) as this will affect the recovery of micro-organisms.
Author :Andrew Cross Document Number: PD-UserHbk-05 ver 1.0, 26/7/2007
TRUST GUIDELINES AND ADVICE Taking Blood Cultures – Standards for Best Practice NOTE: This document should be used in conjunction with the Taking Blood Cultures – Competence Assessment form 1. Blood cultures should be taken when there is reason to suspect a blood stream infection e.g. Sepsis exists when there is evidence or suspicion of infection and two or more of the following Chills with rigors WBC>12000 l-1 Hyperthermia>38.30C Hypothermia<360C Tachycardia>90 min-1 WBC<4000 l-1 Acutely altered mental status Tachypnoea>20 min-1 Gluc>6.6mmol l-1 - Blood cultures should be taken as part of an investigation plan developed after systematic patient assessment. - Blood cultures may not be indicated if sample taken within the previous 24 hours and no new indicators of further systemic infection evident. - If in doubt seek Microbiologist advice.
Requesting
2. Ensure meticulous hygiene - Clean and prepare a clinical trolley with the equipment you will need. - Ensure you are bare below the elbows, wash your hands and use alcohol rub, always wear an apron and gloves. - Clean the patient’s skin at the site where venepuncture will be performed for 30 seconds and allow to dry for 30 seconds (use 2% Chlorhexidine Gluconate in 70% Isopropyl Alcohol). - DO NOT touch the skin after cleaning. This is of utmost importance to prevent contamination of the sample. - Clean the top of each blood culture bottle as for skin cleaning. - If using a syringe and needle to take blood – ensure that a new needle is used to pierce each sample bottle. - If other blood required for other samples, inoculate blood culture bottles first. 3. Take appropriate samples that will be of diagnostic value - Samples should be taken before antibiotics are commenced or immediately before the next dose if already receiving antibiotics. - Collection of blood from peripheral venepuncture is the ‘Gold standard’. (DO NOT use indwelling peripheral cannulae). - In extreme circumstances (e.g. a paediatric patient with one cannulatable vein), if a newly inserted cannula is used for sampling, take all possible measures to avoid contaminating the line & state on request form ‘Blood from new cannula’. - If suspected line-related infection in addition to peripheral venepuncture, collect blood from indwelling intravascular lines in situ for >48 hours (e.g. Central line, Arterial Line, ‘Vas Cath’ , but not peripheral cannula). Ensure the hub is cleaned prior to sample collection as described above for venepuncture. - In multi-lumen lines - blood should be drawn from at least one lumen – preferably the most accessed/manipulated lumen. If TPN is in progress, sample from this port at bag change to minimise the risk of contamination.
4. Communicate information about samples sent for culture - Label the sample bottles clearly after verifying the patient’s identification details according to Trust policy. - Ensure that the patient’s details are also clearly documented on the request form. - State the reason why the sample has been taken (clinical indicators / evidence of infection/sepsis or other relevant medical conditions). - State current/recent antibiotic treatment or ‘Not receiving antibiotics’. - State site of blood collection (‘Peripheral venepuncture’, ‘Blood from new cannula’, ‘Central line blood’, ‘Arterial line blood’, ‘Vas cath blood’). - Ensure that the name of the person who has obtained the blood sample is legibly written on the request form. (To allow audit and maintenance of standards across all professions taking blood culture samples). 5. Maintain clinical competence and clinical standards - All practitioners taking blood samples for culture should have documented evidence of their training and competence. - This should be re-verified by annual assessment (by another competent registered professional) and documented at annual appraisal by the appraiser/manager. - The standards stated here should be audited at least annually within the Trust and results shared with all relevant clinical areas. - These standards are principles aimed at ensuring best practice and maximum diagnostic value. Technical and practical Leefor Cutler Dr Christine 2008. details about techniques and equipment blood /sampling can beHoy, foundMay in Trust training packages, in the Pathology Handbook and are taught in practical workshops. For further details contact the training department. Lee Cutler / Dr Christine Hoy, May 2008.
Lee Cutler / Dr Christine Hoy, May 2008.
AFFIX LABEL HERE IF AVAILABLE
HMR111(g)
Unit Number: .................................................................................................................. Surname: ............................................................................................................................ Forename(s): ................................................................................................................... Address: ..............................................................................................................................
HIGH DOSE EXTENDED-INTERVAL GENTAMICIN PRESCRIPTION AND MONITORING PATHWAY Hospital:
Doncaster
Montagu
......................................................................................................................................................
D.o.B.: ....................................................................................................................................
Bassetlaw
Retford
Tickhill Road
PILOT DOCUMENT
Requesting
Consultant: ...................................................................................................................... Ward: ............................................................................................................................................ Weight (kg): ................................................................. Height (cm): ................................................................ Ideal weight (kg): ................................................................ Prescriber's Responsibility - it is the prescriber's responsibility to: a) Ensure that the gentamicin is not prescribed without full information regarding the patient's renal function and latest gentamicin levels being known - see overleaf. b) To take or ensure that gentamicin level samples are taken at the appropriate time. c) Ensure the request form is legibly completed with the date and time of the last dose and the date and time of the sample, and the request clearly indicates DAILY DOSING. Pre-printed stickers which are available on the wards should be used to supply this information. Dose 5-7 mg / kg (based on ideal body weight). Frequency depends on serum gentamicin levels - see over Exclusion criteria - Endocarditis, pregnancy, children (<16 years), cystic fibrosis, amputees, patients with ascites, major burns, impaired renal function (CrCl<20ml/min), or on other potentially ototoxic or nephrotoxic drugs. FIRST DOSE - YOU MUST NOT PRESCRIBE the first dose of gentamicin before the renal function is established.
Date
Date
Serum Creatinine (micromols/l)
Creatinine Clearance (ml/min) - see over
Infusion
Time of dose
Prescribed by
Time started
Given by
Witnessed Time stopped by
GENTAMICIN ........................................... mg in Sodium Chloride 0.9% 50ml by IV infusion over 30 mins
Serum gentamicin level MUST be taken 6-14 hours after start of infusion, with EXACT time recorded Serum Gentamicin level after FIRST DOSE - See over Date
Time sample taken
Interval between start of infusion and sample
Serum Gentamicin level (mg/ml)
Interval to next dose
YOU MUST NOT PRESCRIBE the next dose before the first level has been established. YOU MUST NOT ADMINISTER the next dose before the first level has been established. Date
Time of dose
Prescribed by
Infusion
Time started
Given by
Witnessed Time by stopped
GENTAMICIN ........................................... mg in Sodium Chloride 0.9% 50ml by IV infusion over 30 mins
GENTAMICIN ........................................... mg in Sodium Chloride 0.9% 50ml by IV infusion over 30 mins
GENTAMICIN ........................................... mg in Sodium Chloride 0.9% 50ml by IV infusion over 30 mins
Serum Creatinine Monitoring At time of first dose and at least three times weekly Serum creatinine Creatinine clearance Date (micromols/l) (ml/min) - see over
WPR? Oct. 2004
Serum Gentamicin Level Monitoring - See over Twice weekly 6-14 hours after the start of the infusion Date Time sample Interval between start Serum Gentamicin Interval to next dose taken of infusion and sample level (mg/ml)
High Dose Extended-Interval Gentamicin Dosage Calculation and Monitoring Sampling Schedule Gentamicin levels samples should be taken between 6 and 14 hours after thet start of the infusion. Note - It is not usually necessary for gentamicin levels to be reported outside normal working hours, provided levels are available before the next dose is due. Samples which require processing out-of-hours MUST be discussed with a microbiologist. In all cases it is imperative that the date and time of last dose administered and the date and time when sample was taken are recorded on the request form. Calculation for ideal body weight if obese (obesity: > ideal body weight + 20%) Male: Ideal body weight (kg) = Height (cm) - 100
Female: Ideal body weight (kg) = Height (cm) - 105
Calculation for creatinine clearance Male: Creat Cl = 1.23 x (140 - age) x wt (kg) serum creatinine (micromol/l)
Female: Creat Cl = 1.04 x (140 - age) x wt (kg) serum creatinine (micromol/l)
Suggested dosing schedule and monitoring: The Hartford Nomogram Check exclusion criteria (see over). If obese, calculate ideal body weight and use to determine dose. Calculate creatinine clearance - if<20 ml/min DO NOT use high dose extended-interval gentamicin
Requesting
Initial dose: 5-7 mg/kg in 50ml sodium chloride 0.9% by intravenous infusion over 30 minutes • Obtain a single serum level after the first dose, between 6-14 hours after the start of the infusion. It is very important that the exact time is documented on both the request form and prescription chart. • Evaluate gentamicin level on the nomogram. If the level falls in the area designated Q24h, Q36h or Q48h, continue the same dose at an interval of 24, 36 or 48 hours respectively. If the point is on the line choose the longer interval. • If treatment continues for longer than four days repeat levels should be monitored twice weekly. • If the level is off the nomogram, stop the scheduled therapy and discuss with microbiologist. • Gentamicin should preferably not be given with other ototoxic or nephrotoxic drugs and whenever possible treatment should not exceed 7 days.
Directorate of Pathology CONSENT TO A POST MORTEM EXAMINATION The Human Tissue Act 2004 sets out a new legal framework for the storage and use of tissue from the living and for the removal, storage and use of tissue and organs from the dead. The Act also established the Human Tissue Authority (HTA) as a regulatory body for all matters concerning the removal, storage, use and disposal of human tissue for scheduled purposes. The Human Tissue Authority has issued codes of practice which are available on the HTA website. The statutory requirements for consent are as follows: The Living: Consent for treatment and examination including removal is a common-law matter dealt with in the Department of Health’s reference guide to consent for examination and treatment. Consent from the living is needed for storage and use of tissue for obtaining scientific or medical information which maybe relevant to any other person now or in the future, research, public display and transplantation. Consent from the living is not needed for storage and use of tissue for: Clinical audit, educational training, performance assessment, public health monitoring. The Deceased: After a Coroner’s post mortem, for the continued storage or use of material no longer required to be kept for the Coroner’s purposes. For the removal, storage and use for the following scheduled purposes:
Requesting
Anatomical examination, to determine the cause of death, and establishing after a person’s death the effects of any drug or other treatments administered to them. To obtain scientific or medical information, public display, research, transplantation, clinical audit, educational training, performance assessment, public health monitoring and quality assurance. Consent is not needed for: Carrying out investigation into the cause of death under the authority of the Coroner. Keeping material after post mortem under the authority of a Coroner for as long as the Coroner requires it. Keeping material in connection with a criminal investigation or following a criminal conviction. Post mortem examination is important for informing relatives, Clinicians and legal authorities about the cause of death. It can also inform bereaved relatives about possible acquired or genetic diseases which may need treatment and care. Post mortem examination may lead to improvements in clinical care, maintenance of clinical standards, increase our understanding of disease and prevent the spread of infectious diseases and may contribute to research and training. Bereaved people should be treated with respect and sensitivity at all times, both to help them take important decisions at a difficult time and to ensure continuing improvements in care. A post mortem examination may take place either because the Coroner (medical/legal autopsy) considers it necessary or because it has been agreed upon by the deceased person or their relatives (voluntary/consent autopsy). Consent is not required for the carrying out of a Coroner’s post mortem, consent is however required for the removal, storage and use of human tissue or organs. Voluntary post mortems require informed consent. Author Title Document No.
Suzanne Rogers Consent to a Post Mortems PD-UserHbk-012 ver1.0
Page 1 of 2 24/05/2007
Discussing the post mortem with the family: who may seek consent? The way in which a post mortem examination is discussed with the deceased person’s relatives or close friends is extremely important. They need to be given honest, clear, objective information; the opportunity to talk to someone they can trust and whom they feel able to ask questions; reasonable time to reach decisions (about a hospital post mortem and about any donation of organs or tissue); privacy for discussion between family members if applicable and support if they need and want it. Only once relatives have had time to reach a decision should they be invited to sign the consent form. Those seeking consent for hospital post mortem examination should be sufficiently senior and well informed, with a firm knowledge of the procedure. They should have been trained in the management of bereavement and know the purpose and procedures of post mortem examinations. It is usually the responsibility of the deceased person’s Clinician to seek consent. Wherever possible, before the discussion with relatives, the responsible Clinician should contact the Pathologist who will perform the post mortem examination. They can give accurate guidance on which if any tissue or organs are likely to be retained, for how long and for what purpose. The Pathologist should also be available for discussion with the deceased person’s relatives if they wish. The current NHS consent forms should be used as a basis for obtaining informed consent. There are accompanying explanatory leaflets which should be made available to the relatives. The various options such as limiting the post mortem examination and the consequence of this should be explained to the relatives.
Requesting
The discussion with the relatives should include a basic explanation of what happens in a post mortem examination; the benefits of a post mortem examination and the questions to be addressed in any particular case. Possible alternatives to a full post mortem examination and any limitations of these alternatives should be explained. Information about tests needed and whether these might cause delays in the process (eg retention of the whole brain) should be explained. Options for what will happen to the body or remains and any organs or tissue removed including tissue blocks and slides should be discussed. The timing of burial or cremation should be established and discussions take place about the uniting of any material with the body for burial or cremation if the relatives so wish. Religious factors, such as the need for quick funerals in the Jewish/Muslim and Hindu faiths should be taken into account. Relatives should be given a copy of the signed consent form and there should be a cooling off period during which relatives may change their mind. Dr Suzanne Rogers Consultant Pathologist February 2007
Author Title Document No.
Suzanne Rogers Consent to a Post Mortems PD-UserHbk-012 ver1.0
Page 2 of 2 24/05/2007
Directorate of Pathology The following document is taken from the Association of Clinical Pathologists (ACP) News Instructions for doctors certifying cause of death The purposes of death certification Death certification serves a number of functions. A medical certificate of cause of death (MCCD) enables the deceased’s family to register the death. This provides a permanent legal record of the fact of death and enables the family to arrange disposal of the body, as well as to settle the deceased’s estate. Information from death certificates is used to measure the relative contributions of different diseases to mortality. Statistical information on deaths by cause is important for monitoring the health of the population, designing and evaluating public health interventions, recognising priorities for medical research and health services, planning health services and assessing the effectiveness of those services. Death certificate data are extensively used in research into the health effects of exposure to a wide range of risk factors through the environment, work, medical and surgical care, and other sources. After registering the death, the family gets a certified copy of the register entry, which includes an exact copy of the cause of death information that you give. This provides them with an explanation as to how and why their relative died. It also gives them a permanent record of information about their family medical history, which may be important for their own health and that of future generations. For all of these reasons it is extremely important that you provide clear, accurate and complete information about the diseases or conditions that caused your patient’s death.
Requesting
Planned changes to death certification The government has announced plans to change the laws on death investigation, certification and the coroner service.1 These changes will address the issues raised by the Shipman Inquiry and the Fundamental Review of Death Certification. However, the law has not changed yet. When new legislation is passed, doctors will receive instructions on the changes and the date from which they should be implemented. Changes are not likely to take effect before 2007-8. This guidance is to remind you of the duties placed on medical practitioners under current legislation, and to clarify best practice. Who should certify the death? When a patient dies it is the duty of the doctor who has attended in the last illness to issue the MCCD if they are able to do so (although see below regarding referral to the coroner). Though there is no clear legal definition of “attended”, this is generally accepted to mean a doctor who has cared for the patient during the illness that led to death and so is familiar with the patient’s medical history, investigations and treatment. The certifying doctor should also have access to relevant medical records and the results of investigations. In hospital there may be several doctors in a team caring for the patient. It is ultimately the responsibility of the consultant in charge of the patient's care to ensure that the death is properly certified. Any subsequent enquiries, such as for the results of post-mortem or ante-mortem investigations, will be addressed to the consultant. In general practice more than one GP may have been involved in the patient’s care and so be able to certify the death. If no doctor who cared for the patient can be found, the death must be referred to the coroner to investigate and certify the cause. If the attending doctor has not seen the patient within the 14 days preceding death, and has not seen the body after death either, the registrar is obliged to refer the death to the coroner before it can be registered. In these circumstances, the coroner may give permission for a doctor who was involved in the patient’s care at some time to certify, despite the prolonged interval, and the registrar will then accept the MCCD. Here practices vary between coroners; some will allow certification by a doctor who attended outside the 14 days and some will not. Yet others disregard the provision for viewing after death, and insist that the doctor issuing the MCCD must have seen the patient in the last 14 days of life. However, a doctor who has not been directly involved in the patient’s care at any time during the illness from which they died cannot certify under current legislation. The doctor should, in these circumstances, provide the coroner with any information that may help to determine the Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 1 of 9 24/05/2007
cause of death. The coroner may then provide this information to the registrar of deaths. It will be used for mortality statistics, but the death will be legally â&#x20AC;&#x153;uncertifiedâ&#x20AC;? if the coroner does not investigate through an autopsy, an inquest, or both. Referring deaths to the coroner Registrars of births and deaths are under a legal duty to report certain categories of deaths to the coroner before they can be registered; these include deaths associated with accident, suicide, violence, neglect (by self or others) and industrial disease. Also deaths occurring during an operation, or before full recovery from an anaesthetic, as well as deaths occurring in, or shortly after release from, police or prison custody should be reported. In practice, doctors usually report such deaths themselves and seek the advice of the coroner. The Office for National Statistics (ONS) encourages doctors to do this and to explain to the family why the death is being referred, as well as how and when they will learn the outcome of the referral. The coroner should also be informed if there is no doctor who attended the deceased available to certify, or the certifying doctor did attend the deceased but has not seen them either within 14 days before death, or after death. Strictly speaking, the doctor should complete an MCCD even when death has been referred to the coroner as, if the coroner decides that the death does not require investigation, the registrar can be instructed to use the doctorâ&#x20AC;&#x2122;s MCCD to register the death. In practice, most coroners ask that a doctor does not complete the MCCD unless directed to do so after discussion.
Requesting
When a death is referred, it is up to the coroner to decide whether or not it should be further investigated. It is very important that the coroner is given all of the facts relevant to this decision. As above, the doctor should discuss the case with the coroner before issuing an MCCD if at all uncertain as to the cause of death, or whether he or she should certify. This allows the coroner to make enquiries and decide whether or not any further investigation is needed, before the family tries to register the death. The coroner may decide that the death can be registered and direct the doctor to complete the MCCD. For example, 75% of deaths with fractured neck of femur mentioned on the certificate are registered from the MCCD completed after discussion with the coroner, whereas only about 15% go to inquest, and 10% are registered after a coroner's autopsy. Omitting to mention on the certificate conditions or events that contributed to the death, in order to avoid referral to the coroner, is unacceptable. If these come to light when the family registers the death, the registrar will be obliged to refer it to the coroner. If the fact emerges after the death is registered, an inquest may still be held. In Scotland, deaths that may have been related to adverse effects of medical or surgical treatment, or to standards of care, or about which there has been any complaint, are reportable to the procurator fiscal. While this is not a requirement in England and Wales, it is anyway advisable to refer deaths in these categories to the coroner. How to complete the cause of death section Doctors are expected to state the cause of death to the best of their knowledge and belief; they are not expected to be infallible. However, it is likely that there will be increased scrutiny of death certification and patterns of mortality by local and national agencies as a result of the Shipman Inquiry, even before any changes to the law. Suspicions may be raised if death certificates appear to give inadequate or vague causes of death. For example, deaths under the care of an orthopaedic surgeon that do not mention any orthopaedic condition or treatment, or deaths in an acute hospital from old age, with no disease, injury or operation mentioned, may prompt further investigation. Doctors who consistently use only vague or uninformative causes of death, or terminal conditions such as bronchopneumonia, may find that these are queried and checked against hospital and/or primary care records. The level of certainty as to the cause of death varies. What to do, depending on the degree of certainty or uncertainty about the exact cause of death, is discussed below. Sequence leading to death, underlying cause and contributory causes The MCCD is set out in two parts, in accordance with WHO recommendations in the International Statistical Classification of Diseases and Related Health Problems (ICD). You are asked to start with the immediate, direct cause of death on line 1a, then to go back through the sequence of events or conditions that led to death on subsequent lines, until you reach the one that initiated the fatal sequence. The condition on the lowest line of part one that is used will usually be selected as the underlying cause of death for statistical purposes. Remember that this underlying cause may be a longstanding, chronic disease or disorder that predisposed the patient to later fatal complications. You should also enter any other diseases, injuries, conditions, or events that contributed to the death, but were not part of the direct sequence, in part two of the certificate. Example: Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 2 of 9 24/05/2007
1a. 1b. 1c. 2.
Intraperitoneal haemorrhage Ruptured secondary deposit in liver Adenocarcinoma of ascending colon Non-insulin dependant diabetes mellitus
1a. 1b. 1c.
Cerebral infarction Thrombosis of basilar artery Cerebrovascular atherosclerosis
In some cases, a single disease may be wholly responsible for the death. In this case, it should be entered on line 1a. Example: 1a. Meningococcal septicaemia More than three conditions in the sequence The MCCD in use in England and Wales currently has three lines in part one for the sequence leading directly to death. If you want to include more than three steps in the sequence, you can do so by writing more than one condition on a line, indicating clearly that one is due to the next. Example: 1a. Post-transplant lymphoma 1b. Immunosuppression following renal transplant 1c. Glomerulonephrosis due to insulin dependent diabetes mellitus 2. Recurrent urinary tract infections
Requesting
More than one disease may have led to death If you know that your patient had more than one disease or condition that was compatible with the way in which he or she died, but you cannot say which the most likely cause of death was, you should include them all on the certificate. They should be written on the same line and you can indicate that you think they contributed equally by writing “joint causes of death” in brackets. Example: 1a. Cardiorespiratory failure 1b. Ischaemic heart disease and chronic obstructive pulmonary disease (joint causes of death) 2. Osteoarthritis 1a. 1b. 1c.
Heart failure Ischaemic heart disease Hypercholesterolaemia, widespread atherosclerosis and non-insulin dependent diabetes mellitus
Where more than one condition is given on the lowest used line of part one, ONS will use the internationally agreed mortality coding rules in ICD-10 to select the underlying cause for routine mortality statistics. However, since 1993 ONS also codes all of the other conditions mentioned on the certificate. These multiple cause of death data are used by ONS in a variety of routine and ad hoc analyses, and are made available for research. This provides useful additional information on the mortality burden associated with diseases that are not often selected as the main cause of death. For example, diabetes mellitus is mentioned on death certificates four times as often as it is selected as the underlying cause of death. In contrast to the above, if you do not know that your patient actually had any specific disease compatible with the mode and circumstances of death, you must refer the death to the coroner. For example, if your patient died after the sudden onset of chest pain that lasted several hours and you have no way of knowing whether he or she may have had a myocardial infarct, a pulmonary embolus, a thoracic aortic dissection, or another pathology, it is up to the coroner to decide what investigations to pursue. Results of investigations awaited If in broad terms you know the disease that caused your patient’s death, but you are awaiting the results of laboratory investigation for further detail, you need not delay completing the MCCD. For example, a death can be certified as bacterial meningitis once the diagnosis is firmly established, even though the organism may not yet have been identified. Similarly, a death from cancer can be certified as such while still awaiting detailed histology. This allows the family to register the death and arrange the funeral; however, you should indicate clearly on the MCCD that information from investigations might be available later. You can do this by circling “2” Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 3 of 9 24/05/2007
on the front of the MCCD for autopsy information, or by ticking box “B” on the back of the certificate for results of investigations initiated ante-mortem. It is important for public health surveillance to have this information on a national basis; for example, to know how many meningitis and septicaemia deaths are due to meningococcus, or to other bacterial infections. The registrar will write to the certifying doctor if a GP, or to the patient’s consultant if in hospital, with a form requesting further details to be returned to ONS. Old age Old age should only be given as the sole cause of death in very limited circumstances. These are that: • You have personally cared for the deceased over a long period (many months or years) • You have observed a gradual decline in your patient's general health and functioning • You are not aware of any identifiable disease or injury that contributed to the death •
You are certain that there is no reason that the death should be reported to the coroner (but see below)
You should bear in mind that coroners, crematorium referees, registrars and organisations that regulate standards in health and social care, may ask you to support your statement with information from the patient's medical records and any investigations that might have a bearing on the cause of death. You should also be aware that the patient’s family may not regard old age as an adequate explanation for their relative’s death and may request further investigation.
Requesting
It would be considered unlikely that patients would die of old age, with no apparent disease or injury, in an acute hospital. Similarly, patients dying under the care of surgeons with no surgical condition, or orthopaedic surgeons with no injury or musculoskeletal condition mentioned, would not be expected to die of old age alone and such certificates may be queried. You can specify old age as the underlying cause of such deaths, but you should mention in part one or part two, as appropriate, any other conditions that may have contributed to the death. If fractures are to be mentioned, the case should first be discussed with the coroner. Example: 1a. Pathological fractures of femoral neck and thoracic vertebrae 1b. Severe osteoporosis 1c. Old age 2. Fibrosing alveolitis 1a. 2.
Old age Non-insulin dependent diabetes mellitus, essential hypertension and diverticular disease
1a. 1b. 1c.
Hypostatic pneumonia Dementia Old age
When the chief medical statistician first advised in 1985 that old age or senility would be accepted as the sole cause of death in some circumstances, he recommended a lower age limit of 70 years. There is no statutory basis for this limit and some crematorium referees have set higher limits for accepting applications for cremation when the only cause of death is old age. The average life expectancy at birth for men is now about 76 years, and for women it is 80 years. After much discussion, the ONS Death Certification Advisory Group has recommended that deaths certified as due to old age or senility alone should be referred to the coroner, unless the deceased was over 80, the conditions listed above are all fulfilled and there is no other reason that the death should be referred. However, some coroners require that they be informed of all deaths where the doctor wishes to give this as the sole cause of death, so they can decide whether or not to allow certification. Natural causes The term “natural causes” alone, with no specification of any disease on a doctor's MCCD, is not sufficient to allow the death to be registered without referral to the coroner. If you do not have any idea as to what disease caused your patient's death, it is up to the coroner to decide what investigations are needed. Organ failure Do not certify deaths as due to the failure of any organ, without specifying the disease or condition that led to the organ failure. Failure of most organs can be due to unnatural causes, such as poisoning, injury or industrial disease. This means that the death will have to be referred to the coroner if no natural disease responsible for organ failure is specified. Example: Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 4 of 9 24/05/2007
1a. 1b. 1c. 2.
Renal failure Necrotising-proliferative nephropathy Systemic lupus erythematosus Raynaud's phenomenon and vasculitis
1a. 1b. 1c.
Liver failure Hepatocellular carcinoma and liver cirrhosis Chronic Hepatitis B infection
1a. 1b.
Congestive cardiac failure Essential hypertension
Conditions such as renal failure may come to medical attention for the first time in frail, elderly patients in whom vigorous investigation and treatment may be contraindicated, even though the cause is not known. When such a patient dies, you are advised to discuss the case with the coroner before certifying. If the coroner is satisfied that no further investigation is warranted, the registrar can be instructed to register the death based on the information available on the MCCD. The registrar cannot accept an MCCD that gives only organ failure as the cause of death, without instruction from the coroner.
Requesting
Abbreviations Do not use abbreviations on death certificates. The meaning may seem obvious to you in the context of your patient and the medical history, but it may not be clear to others. For example, does a death from “MI” refer to myocardial infarction or mitral incompetence? Is “RTI” a respiratory or reproductive tract infection, or a road traffic incident? The registrar should not accept a certificate that includes any abbreviations. You, or the patient's consultant, may be required to complete a new certificate with the conditions written out in full, before the death can be registered. This is inconvenient for you and for the family of the deceased. The same applies to medical symbols. Specific causes of death Stroke and cerebrovascular disorders Try to avoid the term “cerebrovascular accident” if at all possible and consider using terms such as “stroke” or “cerebral infarction” instead. If you cannot avoid the term, be sure to explain to the deceased's family that the death was from a disease, not an accident. Give as much detail about the nature and site of the lesion as is available to you. For example, specify whether the cause was haemorrhage, thrombosis or embolism, and the specific artery involved, if known. Remember to include any antecedent conditions or treatments, such as atrial fibrillation, artificial heart valves, or anticoagulants that may have led to cerebral emboli or haemorrhage. Death related to treatment should be discussed with the coroner before issuing the MCCD and some coroners will require investigation by autopsy, and possibly hold an inquest. Example: 1a. Subarachnoid haemorrhage 1b. Ruptured aneurysm of anterior communicating artery 1a. 1b. 1c.
Intraventricular haemorrhage Warfarin anticoagulation Pulmonary embolism following hysterectomy for uterine fibroids with menorrhagia
Deaths from neoplasms Malignant neoplasms (cancers) remain a major cause of death. Accurate statistics are important for planning care and assessing the effects of changes in policy or practice. Where applicable, you should indicate whether a neoplasm was benign, malignant, or of uncertain behaviour. Please remember to specify the histological type and anatomical site of the cancer. Example: 1a. Carcinomatosis 1b. Small cell carcinoma of left main bronchus 1c. Heavy smoker for 40 years 2. Hypertension, cerebral arteriosclerosis, ischaemic heart disease. You should make sure that there is no ambiguity about the primary site if primary and secondary tumour sites are mentioned. Do not use the terms “metastatic” or “metastases” unless it is clear whether you mean metastasis to, or metastasis from, the named site. Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 5 of 9 24/05/2007
Example: 1a. Intraperitoneal haemorrhage 1b. Widespread metastases to liver 1c. Primary adenocarcinoma of ascending colon 2. Non-insulin dependent diabetes mellitus 1a. 1b. 1c.
Pathological fractures of left shoulder, spine and shaft of right femur Widespread skeletal metastases Adenocarcinoma of breast
(But see above comments regarding discussion of fractures with the coroner.) 1a. 1b.
Lung metastases Testicular teratoma
If you mention two sites that are independent primary malignant neoplasms, make that clear. Example: 1a. Massive haemoptysis 1b. Primary small cell carcinoma of left main bronchus 2. Primary adenocarcinoma of prostate If a patient has widespread metastases, but the primary site could not be determined, you should state this clearly. Example: 1a. Poorly differentiated metastases throughout abdominal cavity 1b. Adenocarcinoma from unknown primary site
Requesting
If you do not yet know the tumour type and are expecting the result of histopathology, indicate that this information may be available later by initialing box “B” on the back of the certificate. You, or the consultant responsible for the patient's care, will be sent a letter requesting this information at a later date. In the case of leukaemia, specify whether it is acute, sub-acute or chronic, and the cell type involved. Example: 1a. Neutropenic sepsis 1b. Acute myeloid leukaemia 1a. 1b. 2.
Haemorrhagic gastritis Chronic lymphocytic leukaemia Myocardial ischaemia, valvular heart disease
Diabetes mellitus Always remember to specify whether your patient’s diabetes was insulin dependent/type one, or non-insulin dependent/insulin resistant/type two. If diabetes is the underlying cause of death, specify the complication or consequence that led to death, such as ketoacidosis. Example: 1a. End-stage renal failure 1b. Diabetic nephropathy 1c. Insulin dependent diabetes mellitus 1a. 1b. 1c. 2.
Septicaemia - fully sensitive Staphylococcus aureus Gangrene of both feet due to peripheral vascular disease Non-insulin dependent diabetes mellitus Ischaemic heart disease
Deaths involving infections and communicable diseases Mortality data are important in the surveillance of infectious diseases, as well as monitoring the effectiveness of immunisation and other prevention programmes. If the patient's death involved a notifiable disease, you should inform your local Health Protection Unit (HPU) about the case, unless you have already done so. If you are not sure whether a case is notifiable, or what investigations are needed, you can get advice from your local HPU or consultant in communicable disease control (CCDC). Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 6 of 9 24/05/2007
In deaths from infectious disease, you should state the manifestation or body site, eg, pneumonia, hepatitis, meningitis, septicaemia, or wound infection. You should also specify: • The infecting organism, eg, pneumococcus, influenza A virus, meningococcus • Antibiotic resistance, if relevant, eg, methicillin resistant Staphylococcus aureus (MRSA), or multiple drug resistant mycobacterium tuberculosis • The source and/or route of infection, if known, eg, food poisoning, needle sharing, contaminated blood products, post-operative, community or hospital acquired, or health care associated infection. You need not delay completing the certificate until laboratory results are available, provided you are satisfied that the death need not be referred to the coroner. However, you should indicate by ticking box “B” on the back of the certificate that further information may be available later. A letter will then be sent to you, or to the patient's consultant, requesting this information. The coded cause of death will then be amended for statistical purposes. Example: 1a. Bilateral pneumothoraces 1b. Multiple bronchopulmonary fistulae 1c. Extensive, cavitating pulmonary tuberculosis (smear and culture positive) 2. Iron deficiency anaemia
Requesting
Failure to specify the infecting organism can lead to unnecessary investigation. For example, every year deaths are certified as being due to spinal or paraspinal abscess, without stating the organism(s) involved. These are then coded as tuberculosis following the ICD index. Unless ONS can establish that the abscess was due to another organism, the local CCDC will then have to investigate whether or not it was TB. Remember to specify any underlying disease or treatment, such as chemotherapy, radiotherapy, autoimmune disease or organ transplant, which may have suppressed the patient's immunity and so led to death from infection. Deaths related to treatment should be discussed with the coroner first. Health care associated infections It is a matter for your clinical judgment as to whether a condition the patient had at death, or in the preceding period, contributed to their death, and so whether it should be included in part one or part two of the MCCD. However, families may be surprised if you do not mention on the death certificate something that they believe contributed to their relative's death. ONS receives frequent queries from a wide range of sources about mortality related to health care associated infections, and complaints about the quality of information given about them on death certificates. Example: 1a. Methicillin resistant Staphylococcus aureus septicaemia 1b. Immunosuppression 1c. Non-Hodgkin’s lymphoma 1a. 1b. 2.
Carcinomatosis Adenocarcinoma of the prostate Chronic obstructive pulmonary disease and catheter-associated Escherichia coli urinary tract infection
Deaths from pneumonia Pneumonia may present in previously fit adults, but often it occurs as a complication of another disease affecting the lungs, mobility, immunity, or swallowing. Pneumonia may also follow other infections and may be associated with treatment for disease, injury or poisoning, especially when ventilatory assistance is required. Remember to specify, where possible, whether it was lobar or bronchopneumonia and whether primarily hypostatic, or related to aspiration. You should include the whole sequence of conditions and events leading up to it. If known, specify whether the pneumonia was hospital or community acquired. If it was associated with mechanical ventilation, or invasive treatment, this should be clearly stated. Example: 1a. Pneumococcal lobar pneumonia 1b. Influenza A 2. Ischaemic heart disease For many years, bronchopneumonia was given as the immediate cause of death on a large proportion of certificates in England and Wales. This may have reflected common terminal chest signs and symptoms, rather than significant infection in many cases. The proportion of certificates that mention bronchopneumonia Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 7 of 9 24/05/2007
has been steadily falling for 20 years. If you do report bronchopneumonia, remember to include any predisposing conditions, especially those that may have led to paralysis, immobility, or wasting, as well as chronic respiratory conditions such as chronic bronchitis. Example: 1a. Aspiration pneumonia 1b. Motor neurone disease 2. Pressure ulcers on sacrum and heels Deaths from injuries All deaths involving any form of injury or poisoning must be referred to the coroner. However, if the death is not one for which an inquest is mandatory and the coroner instructs you to certify, remember to include details as to how the injury occurred and where it happened, such as at home, in the street, or at work. Example: 1a. Pulmonary embolism 1b. Fractured neck of femur 1c. Tripped on loose floor rug at home 2. Moderate left sided weakness and difficulty with balance since haemorrhagic stroke five years ago. Hemiarthroplasty two days after fracture Remember to state clearly if a fracture was pathological, that is due to an underlying disease process such as a metastasis from a malignant neoplasm, or other conditions such as osteoporosis. Deaths due to substance misuse Deaths from diseases related to chronic alcohol or tobacco use need not be referred to the coroner, provided the disease is clearly stated on the MCCD. Example: 1a. Carcinomatosis 1b. Bronchogenic carcinoma upper lobe left lung 1c. Smoked 30 cigarettes a day 2. Chronic bronchitis and ischaemic heart disease.
Requesting
However, deaths due to acute or chronic poisoning, and deaths involving drug dependence, or misuse of substances other than alcohol and tobacco, must be referred. Finally, remember that there are instructions for certifiers in the front of every book of MCCDs. These remain current, except for the change in lower age limit at which â&#x20AC;&#x153;old ageâ&#x20AC;? is thought to be acceptable as the sole cause of death (now 80 instead of 70, as covered in detail above). Doctors should familiarise themselves with the instructions, and consult them if they are in any doubt about whether, or how, to certify a death. 1
Reforming the Coroner and Death Certification Service: A position paper. March 2004, Home Office. Cm 6159.
Dr Cleo Rooney is Medical Epidemiologist at the Office for National Statistics in London E-mail: cleo.rooney@ons.gov.uk
Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 8 of 9 24/05/2007
Deaths which must be referred to the coroner: The cause of death is unknown The death was violent or unnatural, or there are suspicious circumstances The death may be due to: • accident • suicide • self-neglect • neglect by others • an industrial disease, or the deceased’s employment The death occurred during • an operation, or before full recovery from an anaesthetic • detention in police or prison custody, or shortly after release There is no doctor who attended the deceased available to complete the MCCD
Requesting
The deceased was not seen by the certifying doctor either after death or within 14 days before death
Author Title Document No.
Cleo Rooney (Dr S Rogers) ACP Guidance for MCCD PD-UserHbk-013 ver1.0
Page 9 of 9 24/05/2007
Requesting
Human Tissue Authority Code of Practice â&#x20AC;&#x201C; Consent Code 1 July 2006
Contents Paragraphs
Introduction
1–9
The scope of the Human Tissue Act
10 –14
The question of consent
15 –20
The process of consent
67–109
When to seek consent
67–70
Who should seek consent?
71–73
Religion, culture and languages
74–76
What information should be given? – Tissue storage and use from the living
77–80
22–25
– Tissue storage and use from the deceased
81–84
The deceased
26–27
Use of documentation
85–89
Exceptions for research in specific circumstances
28–29
Form of consent
90–96
Written consent
97–100
Who can give consent?
30–66
Statutory requirements for consent
21–29
The living
Tissue from the living
Requesting
Paragraphs
– competent adults
33–34
– adults who lack capacity
35–40
– children
41–44
Tissue from the deceased – adults
45–47
– nominated representatives
48–52
– qualifying relationships
53–59
– children
60–65
Fetal tissue
66
Multiple consents (e.g. post mortem examination/research) 101–103 Nature and duration of consent
104–106
Withdrawal of consent
107–109
Donated material
110
Existing holdings
111–113
Research
114–115
Consent and the use of DNA
116–123
Powers of the court / the Human Tissue Authority to dispense with the need for consent
124–125
Glossary
Introduction 1
Requesting
2
3
The Human Tissue Act 2004 (The Act) which extends to England, Wales and Northern Ireland only, sets out a new legal framework for the storage and use of tissue from the living and for the removal, storage and use of tissue and organs from the dead. This includes ‘residual’ tissue following clinical and diagnostic procedures. The Act repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they relate to England and Wales. It also repeals and replaces the Human Tissue Act (Northern Ireland) 1962, the Human Organ Transplants (Northern Ireland) Order 1989 and the Anatomy (Northern Ireland) Order 1992. There is separate legislation for Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA will perform certain tasks on behalf of the Scottish Executive. For the purpose of these codes, the term ‘NHS Trusts’ includes Health and Social Services (HSS) Trusts in Northern Ireland. The Act also establishes the Human Tissue Authority (HTA) as the regulatory body for all matters concerning the removal, storage, use and disposal of human tissue (excluding gametes and embryos) for scheduled purposes. This includes responsibility for living donor transplantation. This is one of the functions which the HTA will carry out on behalf of the Scottish Executive.
4
The HTA is also responsible for giving advice and guidance on the Act and for licensing establishments that carry out particular activities under the Act.
5
One of the HTA’s statutory functions is to issue codes of practice. This is one of the first six codes, which should be regarded as complementary: 1 Consent 2 Donation of organs, tissue and cells for transplantation 3 Post mortem examination 4 Anatomical examination 5 Removal, storage and disposal of human organs and tissue 6 Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation.
6
These codes give practical guidance to those carrying out activities which lie within the HTA’s remit and lay down the standards expected. These are not a definitive guide to the law and licence holders should refer to the Act and keep themselves informed about future legal developments.
7
The guidance given applies to anyone undertaking relevant activities. Failure to follow this guidance is not in itself a criminal offence under the Act, but the HTA may take any such breach into account when carrying out its responsibilities in respect of licensing.
3
The scope of the Human Tissue Act The codes have been approved by the Secretary of State and laid before Parliament in accordance with Section 29 of the Act.
9
Any references to the terms ‘tissue’, ‘organ’, ‘part organ’, ‘material,‘ ‘body parts’ or ‘cells’ in this code refers to ‘relevant material’. For definitions of terms used, please refer to the glossary at the back of this code.
Requesting
8
4
The scope of the Human Tissue Act 10 The Act, and the HTA’s codes of practice,
encompass consent provisions on: • the storage and use of dead bodies • the removal, storage and use of ‘relevant material’ 1 from a dead body and • the storage and use of relevant material from the living. 11 The Act does not deal directly with
Requesting
the removal of tissue from the living. Although the process of seeking consent for the storage and use of tissue from patients will often be undertaken at the same time as consent to investigation or treatment, the consent for removal itself in these circumstances remains a matter of common law. 12 Consent under the Act relates to the
13 Anyone removing, storing or using
material in circumstances for which the Act requires consent, must be satisfied that the consent is in place. They do not need to have taken or recorded the consent personally, but must ensure that procedures are in place giving the necessary assurance. These procedures should be robust and reviewed regularly. It is a defence that the person acts with a reasonable belief that consent is in place or is not necessary. 14 The use of photographic or electronic
images of human tissue is outside the remit of the Act. However, as part of this code of practice, the HTA endorses the guidance on this issue provided by the General Medical Council: Making and using visual and audio recordings of patients.2
purposes for which material might be stored or used. These purposes are set out in Schedule 1 of the Act and are hereafter referred to as ‘scheduled purposes’.
1 See glossary 2 www.gmc-uk.org/guidance/library/making_audiovisual.asp
5
The question of consent 15 At the heart of the Act lies the need to
obtain consent for the removal, storage and use of human tissue or organs and the storage and use of whole bodies for certain scheduled purposes. This code gives guidance on the need for consent, and also addresses the closely related issues of communication and consultation with patients and their families which should support the consent process. 16 The Act requires consent for the removal,
storage and use of human tissue, but it does not (other than in the cases of donations for anatomical examination and public display after death) define what constitutes appropriate consent.
Requesting
17 The giving of consent is a positive act.
The absence of refusal is not evidence of consent. 18 The Act specifies whose consent is needed
in all the relevant circumstances but it does not generally give details of how consent should be sought or recorded, or of what information should be given. This code advises on these issues. 19 Before deciding whether to proceed with
the removal, storage or use of tissue for scheduled purposes, the following should be considered:
• Who has authority to give consent? (paragraphs 30–66) • Has sufficient written or verbal information been provided for the person giving consent to understand the issues? (paragraphs 77–84) • How will the consent be given and recorded? (paragraphs 85–96) • When is written consent required? (paragraphs 97–100) • Is consent needed for more than one purpose? (paragraphs 101–104) • If a child is involved, is s/he competent to consent and/or has s/he expressed particular wishes or views? (paragraphs 41–44, 60–65) • If an adult who lacks capacity is involved, is s/he competent to make this decision? Is the proposed action in his/her best interests? (paragraphs 35–40) • Is DNA analysis likely to be involved? (paragraphs 116–123) • Is the consent for research appropriately specific/general? (paragraphs 111–115) 20 A person’s agreement or refusal to
consent to the donation, storage or use of tissue for purposes under the Act must not affect the investigation or treatment that s/he receives.
• Does the activity require consent? For post mortem cases consent is required for all scheduled purposes. Consent is not required under the Act for tissue from living patients in some circumstances (paragraphs 21–29). 6
Statutory requirements for consent 21 All those involved in the removal, storage
and use of human tissue in any form should be aware of the following statutory requirements for consent:
The living
in relation to another person, rather than where it might, incidentally, be of future relevance to another person) • research in connection with disorders, or the functioning, of the human body (but see paragraph 28 below) • public display, and • transplantation.
22 Consent for treatment and examination
Requesting
including removal is a common law matter dealt with in the Department of Health’s Reference guide to consent for examination and treatment.3 Under the Act, tissue may be taken in a variety of circumstances. For example: • in the course of diagnostic procedures, e.g., taking a blood or urine sample, tissue biopsy, cervical screening, etc. • in the course of a treatment procedure, e.g., removing tissue (organs, tumours, etc.) during surgery • when removed specifically for the purpose of research.
25 Consent from the living is not needed
for storage and use of tissue for: • clinical audit • education or training relating to human health (including training for research into disorders, or the functioning, of the human body) • performance assessment • public health monitoring • quality assurance.
The deceased 26 Consent is needed:
23 Once tissue has been taken from patients,
for whatever purpose, it can be stored and used without consent for a number of purposes. 24 Consent from the living is needed for
storage and use of tissue for: • obtaining scientific or medical information which may be relevant to any other person, now or in the future (i.e. where the purpose is storage or use
• where, after a coroner’s post mortem, the continued storage or use of material no longer required to be kept for the coroner’s purposes • for the removal, storage and use for the following scheduled purposes: – anatomical examination – determining the cause of death – establishing, after a person’s death, the efficacy of any drug or other treatment administered to them
3 www.dh.gov.uk/policyandguidance/healthandsocialcaretopics/consent/consentgeneralinformation/ The DHSSPS (Northern Ireland) has published its own reference guide to consent for examination and treatment: http://www.dhsspsni.gov.uk/consent-referenceguide.pdf
7
Who can give consent?
Requesting
– obtaining scientific or medical information, which may be relevant to any other person now or in the future (‘a future person’) – public display – research in connection with disorders, or the functioning, of the human body – transplantation – clinical audit – education or training relating to human health – performance assessment – public health monitoring and – quality assurance. This applies to all tissue removed at post mortem, including small samples such as blocks and slides, and samples that might be kept as part of the record. For detailed guidance, see the HTA’s Code of practice on post mortem examination, the Coroner’s (Amendment) Rules 2005 4 and the Coroner’s Practice and Procedure Rules (Northern Ireland) 1963. 27 Consent is not needed for:
• carrying out an investigation into the cause of death under the authority of a coroner • keeping material after a post mortem under the authority of a coroner, for as long as the coroner requires it • keeping material in connection with a criminal investigation or following a criminal conviction.
Exceptions for research in specific circumstances 28 Tissue from the living may be stored
for use and/or used without consent, provided that: • the research is ethically approved5 • the tissue is anonymised such that the researcher is not in possession of information identifying the person from whose body the material has come and is not likely to come into possession of it. This does not mean that samples must be permanently and irrevocably unlinked – linking can be made through a third party where necessary – nor that the persons holding the samples cannot themselves carry out the research. If members of the clinical team take part in the research, links may be retained to the relevant clinical or patient records, but they must not contain information giving direct patient identification. 29 In general, obtaining consent is preferable
to developing complex systems for keeping samples unlinked. It represents best practice and has the added benefit of facilitating the process of obtaining ethical approval.
4 www.opsi.gov.uk/si/si2005/20050420.htm 5 Defined under Regulations 2006 (The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) to mean approval given by a research ethics authority.
8
Who can give consent? 30 The general legal principles applying to
consent for treatment and examination apply equally to consent for the storage and use of tissue for other purposes. Guidance is available from the Department of Health’s Reference guide to consent for examination and treatment. 31 For consent to be valid it must be given
voluntarily by an appropriately informed person who has the capacity to agree to the activity in question.
Requesting
32 The seeking and taking of consent from
patients before death or from those close to them after their death, demands great sensitivity. This is especially true for donations for transplantation, post mortems and the retention of tissue and organs for research, etc. (Comprehensive guidance is set out in the Codes of practice on post mortem examination and Donation of organs, tissue and cells for transplantation and the following information should be read in conjunction with those codes).
Tissue from the living – competent adults 33 If an adult is competent, only they are
permitted to give consent. 34 The Act allows residual tissue samples left
over following a diagnostic or therapeutic intervention or research to be disposed of lawfully. However, residual tissue is often an important source of material for research, and surgical consent forms may
include an agreement to the use of such tissue for purposes such as research, education and training.
Tissue from the living – adults who lack capacity 35 Adults are competent to consent if
they can: • understand the nature and purpose of the proposed procedure • understand and retain information relevant to the decision • weigh the necessary information to arrive at a choice. 36 The Act does not specify the criteria for
considering whether an adult has capacity. This should be approached on the same basis as considerations of competency to consent to medical procedures. (While the basis for considering whether an adult has capacity will be the same, the conclusion could differ, as some people might have the capacity to make some decisions, but not others). Guidance is available from the Department of Health’s Reference guide to consent for examination and treatment. In addition, regard must be had to the provisions of the Mental Capacity Act 20056 (MCA 2005). The MCA 2005, which comes into force in 2007, governs decision-making on behalf of adults who lack capacity including adults who lose mental capacity during their lifetime and those with an incapacitating condition from birth. MCA 2005 defines persons
6 http://www.opsi.gov.uk/acts/acts2005/20050009.htm. Note this Act does not extend to Northern Ireland.
9
Who can give consent? who lack capacity and contains a set of key principles and a checklist to be used in ascertaining best interests. 37 It should be assumed that a person is
competent to make a decision unless there is reason to believe otherwise. Individuals affected by trauma, illness, shock, etc., are sometimes temporarily unable to make a decision. Some adults may be competent to make decisions about some matters, but not others. Care should be taken to ensure that patients are given every opportunity, and support where needed, to understand what is proposed.
Requesting
38 The ability of adults with learning
difficulties, or with limited capacity, to understand should not be underestimated. Where appropriate, someone who knows the individual well, such as a family member or carer, should be consulted as s/he may be able to advise or assist with communication. 39 Storage or use of tissue from adults who
lack capacity, other than in accordance with the Regulations under the Act, is unlawful and is an offence under the Act. 40 The Act enables the Secretary of State
to make Regulations setting out the circumstances in which it is lawful to store, or use for a Schedule 1 Part 1 purpose, relevant material from an adult who lacks capacity to consent.
The Regulations7 provide for the circumstances in which consent can be deemed to be in place. These are: • storage and use of relevant material for certain scheduled purposes by a person who is acting in what s/he reasonably believes to be in the best interests of the person lacking capacity from whose body the material came. The scheduled purposes provided for under the Regulations are obtaining scientific or medical information about a living or deceased person which may be relevant to another (including a future person) and transplantation. • storage and use of relevant material from a person who lacks capacity for the purposes of a clinical trial authorised and conducted in accordance with the clinical trials Regulations. 8 • where it is consistent with sections 30–34 of MCA 2005, allowing for the storage and use of relevant material from persons lacking capacity for research in circumstances provided for in that Act. However, as MCA 2005 is not expected to take effect until 2007, these Regulations will, in the meantime, (in the case of England and Wales) 9 allow for the storage and use of relevant material for certain research where it is ethically approved by a Research Ethics Authority and in accordance with the Regulations.
7 Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006. 8 Clinical Trials Regulations are the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031 (or any amending or replacing Regulations) and any other Regulations designated as such by the Secretary of State. 9 The MCA 2005 does not extend to Northern Ireland and accordingly the research must always be approved by a Research Ethics Authority.
10
Who can give consent? Tissue from the living – children 41 Under the Act, a child is defined as being
under 18 years old. 42 Children may consent to a proposed
medical procedure or the storage and use of their tissue if they are competent to do so. In the Gillick10 case, the court held that a child is considered to be competent to give valid consent to a proposed intervention if they have sufficient intelligence and understanding to enable them fully to understand what is involved. Seeking consent from children is dealt with in the Department of Health’s guide Seeking Consent: working with children. 11
Requesting
43 A person who has parental responsibility
for the child can consent on his/her behalf only if the child has not made a decision and: • is not competent to do so; or • chooses not to make that decision, although s/he is competent to do so. A person who has parental responsibility will usually, but not always, be the child’s parent. 12 44 However, it is good practice to consult
the person who has parental responsibility for the child and to involve them in the process of the child making a decision. It is also important to make sure that a child
has consented voluntarily and has not been unduly influenced by anyone else. Courts have identified certain important decisions which require court approval where one person with parental responsibility consents against the wishes of another. If there is any dispute between persons with parental responsibility or any doubt as to the child’s best interests, the matter should be referred to court for approval.
Tissue from the deceased – adults 45 Where an adult has, whilst alive and
competent, given consent for one or more of the scheduled purposes to take place following their death, then that consent is sufficient for the activity to be lawful. This applies in respect of all the scheduled purposes. 46 However, in the case of donation of
the deceased person’s body or relevant material for anatomical examination (other than excepted material) or for public display, consent needs to be written down (the deceased person’s signature, or oral consent recorded) and witnessed (see paragraphs 67 onwards below). There is an exemption for excepted material which is defined as material which has come from the body of a living person or from a deceased person’s body obtained other than in the course of an
10 Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL). 11 http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/ PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4007005&chk=xFifXP 12 The category of persons with parental responsibility is as set out in the Children Act 1989 as amended. Further guidance is available in the Department of Health’s Reference guide to consent for examination and treatment.
11
Who can give consent? anatomical examination. Neither the next of kin nor any other person can agree to the use of an individual’s body after their death for these purposes. 47 If the family or those close to the
Requesting
deceased person object to the donation, for whatever purpose, when the deceased person (or his/her nominated representative – see below) has explicitly consented, clinicians should seek to discuss the matter sensitively with them. They should be encouraged to accept the deceased person’s wishes and it should be made clear that they do not have the legal right to veto or overrule those wishes.
Tissue from the deceased – nominated representatives 48 If a deceased adult has neither consented
to nor specifically refused any particular donation or the removal, storage or use of their body or tissue or scheduled purposes, those close to them should be asked whether a nominated representative was appointed to take those decisions. 49 A nominated representative is empowered
to consent to the carrying out of a post mortem and to the removal, storage and use of the body or tissue for any of the scheduled purposes, other than anatomical examination and public display.
50 The appointment of a nominated
representative and its terms and conditions may be made orally or in writing. If in writing, it must be signed by the person making it, or signed at their direction in the presence of a witness who attests the signature, or be contained in a valid will. If made orally, it must be made before two witnesses present at the same time. If someone comes forward as a nominated representative, their authority to act on the deceased person’s behalf must be verified, including what decisions they have the authority to make. The Act sets out the requirements for a valid appointment. The appointment of a nominated representative may be revoked at any time. 51 If the deceased person appointed more
than one nominated representative, only one of them needs to give consent, unless the terms of the appointment specify that they must act jointly. 52 The nominated representative’s consent
cannot be overridden by other individuals, including family members. It is advisable, nevertheless, to ensure that appropriate consultation and discussion takes place between all those involved. The nomination may be disregarded if no-one is able to give consent under it, which includes where it is not reasonably practicable to communicate with the nominated representative within the time available if the consent is to be acted upon.
12
Who can give consent? Tissue from the deceased – qualifying relationships 53 If the deceased person has not indicated
Requesting
their consent (or refusal) to post mortem removal, storage or use of their body or tissue for scheduled purposes, nor appointed a nominated representative (or the nomination has been disregarded in accordance with paragraph 52), then the appropriate consent can be given by someone in a ‘qualifying relationship’ to the deceased immediately before their death. Those in a qualifying relationship to the deceased person are (highest first): a) spouse or partner (including civil or same sex partner) 13 b) parent or child (in this context a ‘child’ can be any age) c) brother or sister d) grandparent or grandchild e) niece or nephew f) stepfather or stepmother g) half-brother or half-sister h) friend of long standing. 54 Consent should be obtained from the
person ranked highest.
highest ranking, it is sufficient to obtain the consent of any of them. For example, if the deceased person has no spouse or partner, but has several children, the consent of only one child is required. 57 In applying the principles set out above,
a person's relationship shall be left out of account if: • they do not wish to deal with the issue of consent • they are not able to deal with that issue, or • having regard to the activity in relation to which consent is sought, it is not reasonably practicable to communicate with that person within the time available if consent in relation to the activity is to be acted on. This means a person can be omitted from the hierarchy if they cannot be located in reasonable time for the activity in question to be addressed, declines to deal with the matter or is unable to do so, for example, because they are a child or lack capacity. In such cases, the next person in the hierarchy would become the appropriate person to give consent.
55 Relationships listed together, for example
‘brother or sister’, are accorded equal ranking, in which case it is sufficient to obtain consent from just one of them, provided they are ranked equal highest. 56 If the relationship of each of two or more
persons to the deceased is accorded equal
58 While the Act is clear about the hierarchy
of consent, the person giving consent should be encouraged to discuss the decision with other family members. 59 Seeking and obtaining consent can be a
difficult task and healthcare professionals
13 Section 54(9) states for these purposes a person is another person’s partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship
13
Who can give consent? need the sympathetic support and guidance of their seniors/managers to develop the necessary skills. NHS Trusts and other establishments should ensure that appropriate training is given where necessary. (More detail on obtaining consent from those in qualifying relationships and handling disagreements between relatives, is given in the Code of practice on post mortem examination).
Tissue from the deceased – children
Requesting
60 The position of a child who, before they
died, was competent to reach a decision and gave consent for one or more of the scheduled purposes to take place after their death, is no different from that of an adult. Their consent is sufficient to make lawful the removal, storage or use of tissue for that purpose. 61 In the case of anatomical examination
(other than excepted material – see paragraph 46 above) or public display, written, witnessed consent is needed. As with adults, neither the next of kin nor any other person can agree to the use of a child’s body after death for these purposes.
be advisable to discuss with the person who had parental responsibility for the deceased child whether the child was indeed competent to make the decision. 63 If a child did not make a decision, or
was not competent to make a decision, the Act makes clear that the appropriate consent will be that of a person with parental responsibility for the child. The consent of only one person with parental responsibility is necessary. 64 The issue should be discussed fully with
relatives and careful thought should be given as to whether to proceed if a disagreement arises between parents or other family members. Any previously stated wishes of the deceased child should be considered, taking into account their age and understanding. (Further guidance on these points is included in the Codes of practice on post mortem examination and Donation of organs, tissue and cells for transplantation.) 65 If there is no person with parental
responsibility (e.g., if the parents have also died, perhaps at the same time as the child), then consent should be sought from someone in a qualifying relationship, as set out in paragraph 53 above.
62 Clearly, in any case where a child has
consented to the use of their body or any tissue, it is essential to discuss this with the child’s family and to take their views and wishes into account before deciding how to proceed. In some cases it may also 14
Who can give consent? Fetal Tissue 66 The law does not distinguish between
Requesting
fetal tissue and other tissue from the living â&#x20AC;&#x201C; fetal tissue is regarded as the motherâ&#x20AC;&#x2122;s tissue. However, because of the sensitivity attached to this subject, consent should be obtained for the examination of fetal tissue and for its use for all scheduled purposes, regardless of gestational age. It is considered good practice, that wherever practicable, consent should also be obtained for the use in research of nonfetal products of conception. Research Ethics Committee approval is always required for the use of fetal tissue and products of conception in research. (For guidance on the disposal of fetal tissue see the Code of practice on removal, storage and disposal of human tissue).
15
The process of consent When to seek consent
Who should seek consent?
67 Consent is usually sought in a clinical
71 It is the treating clinician’s responsibility
setting for treatment, research, or following the death of a patient. But this is not always the case. Samples may be sought from volunteers in research settings outside a medical or clinical context. The following paragraphs refer generally to clinical settings, but apply equally to other circumstances.
Requesting
68 It is important to establish clearly when
consent has been given, to ensure the removal, storage or use of any tissue is lawful. However, giving consent should not be seen as a single act – the signing of a consent form. Rather, it should be seen as part of a continuing process in which individuals, and their relatives or close friends, can discuss the issue fully, ask questions and make an informed choice. 69 For major interventions, it is good practice
where possible to seek the person’s or donor’s consent to the proposed procedure well in advance. There is then time to respond to their questions and provide adequate information. Clinicians should check before starting the procedure that the person still consents. 70 Equally, discussions with relatives can
often take place in hospital prior to a person’s death. Relatives may know the person’s wishes in respect of, for example, donating organs for transplantation.
to seek consent from a person, person with parental responsibility or relative. The clinician may delegate this task to someone else, usually another healthcare professional, as long as that person is suitably trained and qualified. In particular, they must know enough about the proposed treatment, the intended use of the tissue and the risks involved to adequately brief the person. Responsibility may be given to a dedicated transplant coordinator or to an appropriately qualified member of a bereavement services team. 72 Anyone seeking consent for a hospital
post mortem examination should be sufficiently senior and well informed, with a thorough knowledge of the procedure. They should have been trained in the management of bereavement and in the purpose and procedures of post mortem examinations and they should have witnessed a post mortem examination. 73 It is usually the responsibility of the
deceased person’s clinician to seek consent, knowing the medical problems and the unresolved aspects that merit investigation. There may be different options for choosing who actually discusses the post mortem and obtains consent, but most will involve a team approach. Every establishment carrying out these activities must have an effective
16
Who can give consent? procedure in place. Responsibility for obtaining consent should not be delegated to untrained or inexperienced staff.
Religion, culture and language 74 Attitudes towards the use of tissue, and
Requesting
especially towards post mortems, can vary widely among cultures and religions. All healthcare professionals must be sensitive to this. However, each case and decision is an individual and personal one, and must be treated as such. NHS Trusts and other establishments should ensure their employees are given the necessary training and support to help them identify and meet the widest possible range of needs and wishes. 75 Valid consent can only be given if proper
communication has taken place. Particular consideration should be given to the needs of individuals and families whose first language is not English. Where consent forms are used, these should be available in English and the main local community languages. Staff should take care to establish whether or not those concerned can read them. 76 If necessary, information should be made
available in other formats, such as video or audiotape. Wherever possible, professional translators trained in interpreting for the bereaved and in maintaining confidentiality should be used.
17
What information should be given? Tissue storage and use from the living 77 To give consent, patients (or the
person with parental responsibility) must understand the nature and purpose of what is proposed and be able to make a balanced judgement. They should be told of any ‘material’ or ‘significant’ risks inherent in the way the sample will be obtained, how the tissue will be used and any possible implications of its use, e.g., genetic tests.
Requesting
(If the person concerned is not a patient, and is volunteering samples purely for research, the general principles of providing adequate information should still apply.) 78 Clinicians should try to find out about
patients’ individual needs and priorities when telling them about their options. Some patients may not be interested in knowing about the proposed use of the tissue and it is good practice to record this fact in the notes. Patients should nevertheless have all their options explained to them and be provided with an appropriate level of information.
which has ethical approval) or specific. If it is the latter, detailed information about the research project should be provided, in line with good practice. 80 Patients should be told if their samples
will or could be used for research involving the commercial sector. They should be given appropriate information on the range of activities and researchers which may be involved and whether these include commercial pharmaceutical companies.
Tissue storage and use from the deceased 81 Whether seeking consent from a
nominated representative or from a person in a qualifying relationship, full and clear information should be provided to allow him/her to make a properly considered decision. This information should include the nature of the intended activities and the reasons for them. It should be borne in mind that some people will want more detail than others about, for example, post mortem procedures (see Code of practice on post mortem examination).
79 If identifiable tissue is to be used for
research, patients should be told about any implications this may have. For example, they may be contacted by researchers, given feedback, or be asked for access to their medical records. Patients should be told whether the consent is generic (i.e. for use in any future research project
82 Care should be taken regarding the
possible disclosure of information, such as genetic information or HIV status, which the deceased person may not have wished to be disclosed, or which may have significant implications for other family members. 18
Who can give consent? 83 While consent is needed from only one
person in the hierarchy of qualifying relationships (paragraph 53 above), it is always important to consider the particular circumstances of the family. Information should be given to those who may need it, and discussions about the options available should involve the wider family wherever appropriate. (More detailed guidance on discussion with relatives is included in the Code of practice on post mortem examination.) 84 The way in which the options are
Requesting
discussed with the deceased person’s relatives is extremely important. They should be approached with sensitivity and given: • honest, clear, objective information • the opportunity to talk to someone they can trust, and of whom they feel able to ask questions • reasonable time to reach decisions (about a hospital post mortem and about any donation of organs or tissue) • privacy for discussion between family members, if applicable and • support if they need and want it, including the possibility of further advice or psychological support.
Use of documentation 85 Standard information leaflets are useful
and recommended for: • post mortem (short and long versions) and • anatomical examination. 86 It is helpful to give information about
research projects – usually this is required when giving ethical approval. 87 Many establishments, including NHS
Trusts, have policies on consent that include the use of standard documentation. Such documentation should be reviewed to ensure that it is consistent with the Act and with this code, as well as the requirements of the Clinical Negligence Scheme for Trusts and the relevant Department of Health consent guidance. 88 Consideration should be given as to
whether, in the case of residual tissue from patients, the documentation includes details of the purposes for which tissue may be stored and used and for which consent is not required – for example, clinical audit, quality control, public health monitoring, education and training and research (subject to the anonymisation of samples and ethical approval). 89 Where appropriate, leaflets and forms
should be available in a number of local languages and in a variety of formats, e.g., Braille, audio-visual, etc. 19
Who can give consent? Form of consent 90 The guidance in the code is based on
these key principles:
Requesting
• as a first step, a willingness to discuss the question of consent should be established • full information about the consent process should be provided where possible and in a variety of formats • consent must be based on an understanding of what the procedure involves • consent need not always be given in writing to be appropriate and informed • consent should be generic, i.e. consent could be obtained for all scheduled purposes, where appropriate. 91 The validity of the consent does not
depend on the form in which it is given except for anatomical examination and public display. The information required and the manner in which consent is taken and recorded can vary depending on the particular circumstances. 92 Seeking consent is a process which
involves listening, discussing, and questioning so as to arrive at a shared understanding – a signed form is not necessarily an indication that such an understanding has been reached. For consent to be valid it must be given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question. If these elements have not been satisfied, a signature on a form will not make the consent valid.
93 The Act requires that consent must be in
writing for anatomical examination and public display, but not for other scheduled purposes. Nevertheless, it is good practice to obtain written consent for significant procedures such as post mortem or organ donation. 94 Consent may be expressed verbally or
non-verbally. An example of non-verbal consent would be where a person, after receiving appropriate information, holds out an arm for blood to be taken. 95 When consent is obtained for future
storage or use of samples, but the consent itself is not in writing, an appropriate note should be kept of the fact that consent has been given, and for what purpose(s). This could be entered in the patient record, the laboratory records, or both. 96 The process of seeking, gaining and
recording consent should be appropriate and proportionate to the type of procedure for which it is being obtained, the sample required and its proposed use. Those involved in seeking consent should receive training and support in the implications and essential requirements of taking consent.
20
Who can give consent? Written consent 97 Written consent is always needed for
anatomical examination and the use of dead bodies, or body parts, for public display. (See the Codes of practice on anatomical examination and public display for detailed guidance). 98 Written consent should be obtained
wherever possible for all other post mortem activities, such as the post mortem itself, and the removal of organs or tissue for transplantation (see paragraph 92 above).
102 Equally, if consent has been given to the
use of tissue or organs post mortem for transplantation, it may be helpful to seek consent for storage and use for research purposes. In such cases, the necessary consents should ideally be sought in a single consent process and, where possible, on a single consent form. 103 In the case of post mortem tissue,
all storage and use requires consent, including storage and use of retained samples for all scheduled purposes.
Nature and duration of consent
Requesting
99 As noted earlier, written consent is good
practice for significant procedures such as post mortem or organ donation. If verbal consent is obtained, this should be clearly noted in the patient’s records.
104 When a person gives valid consent to an
intervention, that consent usually remains valid unless the person withdraws it. 105 Consent can be:
100 Model consent forms will be available on
the HTA’s website14.
Multiple consents (e.g. post mortem examination/research) 101 When someone has died, it may be
appropriate to seek consent for more than one of the scheduled purposes. For example, if a post mortem examination is to be carried out, some tissue samples could also usefully be taken for research purposes. In this case, it would be appropriate to seek the relevant consent to both activities.
• general, i.e. if someone consents to the use of tissue for research, it need not be limited to a particular project • specific, i.e. a person limits their consent – a sample can only be used for research into a particular condition • both general and specific, i.e. a general consent subject to specific exceptions. 106 When seeking consent, clinicians
should ensure that it is appropriate to the intended purposes, and that the person understands this.
14 In Northern Ireland, HSS Trusts and other relevant organisations should use the standardised consent forms agreed with the DHSSPS.
21
Who can give consent? Withdrawal of consent 107 A competent person is entitled to
withdraw consent at any time. However, if samples have already been used for a purpose such as research, the withdrawal of consent to any further use does not mean all existing information has to be withdrawn from the research project. Nevertheless, as set out in paragraph 29, it is generally good practice to meet the wishes of patients regarding the use to which their samples are put.
Requesting
108 If someone withdraws consent to the
storage or use of tissue for scheduled purposes such as research, this does not necessarily mean that the sample or samples have to be removed or destroyed. If samples from a living person are being stored for the purpose of maintaining a diagnostic record, or for other purposes such as audit or quality control, consent is not required. 109 But, if consent to the storage or use
of post mortem samples by whoever originally consented to their storage or use is withdrawn, this must be respected for any samples that are still held. Clinicians should discuss with the person concerned how the samples should be returned to them or disposed of, and tell him/her about any samples that may have already been used or disposed of.
22
Donated material 110 In addition under section 8 of the Act,
where the body of a deceased person or relevant material from a human body is the subject of appropriate consent (i.e. donated material), it may not be used or stored for use for purposes other than: â&#x20AC;˘ Scheduled 1 purpose â&#x20AC;˘ Medical Diagnosis or treatment â&#x20AC;˘ Disposal
Requesting
A person who uses or stores such material for any other purpose will commit an offence and will be liable to a fine and / or term of imprisonment of up to three years. It is a defence that the person reasonably believes that the body or material is not donated material.
23
Existing Holdings 111 It is lawful to store and use for scheduled
purposes, without consent, human tissue that is already held in storage for a scheduled purpose on 1 September 2006. However, where the views of the deceased person or of their relatives or friends are known, those views must be respected.
Requesting
112 Collections of organs and tissue can make
an important contribution to training, education, audit and public health monitoring. Computerised images and photographs are not always an adequate substitute. Some of these collections are irreplaceable and of national or international importance. The fact that there is no evidence of consent to their storage and use should not be a reason for destroying existing collections. Samples may be retained and used for these purposes without consent. 113 If the family of a deceased person asks for
the return or disposal of tissue or organs, their request should be complied with â&#x20AC;&#x201C; unless the samples are retained under the authority of a coroner, or in connection with criminal justice purposes.
24
Research 114 There are no statutory requirements as to
the need for consent to the storage or use of tissue (whether from living patients or post mortem) from existing holdings for research. This does not mean that all such human tissue can be used freely and without regard to issues of consent or other ethical considerations. In the case of organs or tissue used for research, the HTA endorses the principle that research should be ethically approved by a research ethics authority and that the potential benefits must outweigh any potential harm to donors of the samples.
Requesting
115 Where the use for research of existing
stored tissue (which may include post mortem samples retained following hospital or coroner’s post mortems) is proposed for the first time, a decision should be taken as to whether consent (or further consent) needs to be sought. The following questions require consideration: (i) has valid consent previously been given? (ii) can it still be considered as valid today? (iii) where valid consent has not already been obtained, can it be obtained from the donor, or if the person concerned is no longer alive, from someone who is or was close to him/her? (iv) where the identity of the donor is unknown or s/he cannot reasonably be traced, such tissue should not be
15 http://www.dh.gov.uk/assetRoot/04/10/41/56/04104156.pdf 16 http://www.mrc.ac.uk/pdf-tissue_guide_fin.pdf 17 http://www.mrc.ac.uk/pdf-nervous_tissue_guidance.pdf
used without careful consideration; although it would be wrong to conclude that the use of unidentifiable tissue is necessarily unethical. (v) additionally, in the case of unidentifiable organs and tissue removed surgically, • whether there is suitable tissue for which valid consent has already been given or could be obtained? and • whether the researcher has satisfied him/herself that there is no evidence that the samples have been obtained unethically or that there are no other ethical concerns regarding usage? (vi) whether the samples constitute unidentifiable organs and tissue removed at post mortem? (vii) whether the research anticipated or proposed constitutes genetic research? Further guidance is provided in ACGT’s Advice to Research Ethics Committees (1998) 15, the MRC’s Guidance on Human Tissue and Biological Samples for Use in Research: Operational and Ethical Guidelines (2001) 16 and the MRC’s Research using Human Nervous System Material (2003): Interim Guidance17.
25
Consent and the use of DNA 116 The consent requirements of the Act do not
make separate provision for DNA or other genetic analysis. Where consent has been given for the removal, storage or use of tissue and organs for Scheduled Purposes, it is lawful to carry out that activity by means of DNA analysis. This does not mean that it would always be good practice to do so without seeking specific agreement to the genetic analysis. The relevant professional guidance should be sought in circumstances in which agreement to the use of genetic analysis is or is not required when carrying out activities for which general consent has otherwise been given.
Requesting
117 While consent makes it lawful to store and
use tissue for Scheduled Purposes, it is an offence under section 45 of the Act to have any bodily material (i.e. material which has come from a human body and which consists of or includes human cells) with intent to analyse the DNA in it without qualifying consent, subject to certain exceptions. Unlike the other parts of the Act, which do not apply to Scotland, this offence applies to the whole of the UK. 118 The offence does not apply if the
results of the analysis are to be used for ‘excepted’ purposes. The following are ‘excepted’ purposes: • medical diagnosis or treatment of that person • coroner/procurator’s fiscal purposes • prevention/detection of crime or prosecution • national security
• court/tribunal order or direction • where the bodily material is from the body of a living person – use for clinical audit, education or training relating to human health, performance assessment, public health monitoring and quality assurance • where the bodily material is an existing holding – use for clinical audit, determining the cause of death, education or training relating to human health, establishing after death the efficacy of any drug or treatment administered, obtaining scientific or medical information about a living or deceased person which may be relevant to another person (including a future person), performance assessment, public health monitoring, quality assurance, research in connection with disorders or functioning of the human body and transplantation • where the DNA has come from an adult lacking capacity under the law of England, Wales and Northern Ireland or is an adult with incapacity under the law of Scotland and neither a decision of that person to or not to consent is in force, use for any purposes specified in Regulations made by the Secretary of State (see below), • obtaining scientific or medical information about the person from whose body the DNA has come where the bodily material is the subject of either a direction by the HTA or a court order under paragraph 9 Schedule 4 of the Act and the information may be relevant to the person for whose benefit the direction or order is made, and 26
Who can give consent? • research in connection with disorders or functioning of the human body, provided the bodily material comes from a living person, the person carrying out the analysis is not in, and not likely to come into, possession of identifying information and the research is ethically approved by a research ethics authority. The Secretary of State may also specify the circumstances in which the High Court, or in the case of Scotland, the Court of Session may order that use of the results of DNA analysis for research purposes is an ‘excepted’ purpose.
Requesting
119 For the purposes of the offence of non-
consensual analysis of DNA, an existing holding is defined as bodily material held immediately prior to commencement of section 45 of the Act. 120 If consent to use material has been
obtained under the Act for a Scheduled Purpose, other than anatomical examination or public display, it is not necessary to obtain separate consent where that use involves DNA analysis. 121 Under Regulations 18 made by the Secretary
of State, the following are ‘excepted’ purposes for which DNA analysis from adults who lack capacity, or in the case of Scotland, adults with incapacity, can be carried out in the circumstances set out in paragraph 117 above:
England, Wales and Northern Ireland: • Any purpose which the person analysing the bodily material reasonably believes to be in the person’s best interests; • Purposes of a clinical trial authorised and carried out in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004; and • Research which is ethically approved where – the research is in connection with disorders or the functioning of the human body; – there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the research is confined to, or relates only to, persons who have capacity to consent to taking part in it, and – there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out in circumstances such that the person carrying out the research is not in possession of information identifying the person from whose body the material has come and is not likely to come into possession of it. In this bullet point, reference to material means bodily material in relation to which an analysis of DNA is to be carried out.
18 See Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
27
Who can give consent? Additionally, in the case of England and Wales only: • Purposes of intrusive research under the Mental Capacity Act, 2005 in accordance with sections 30 – 33 or 34 of that Act which is carried out on or after commencement of section 30 of that Act.
Requesting
Scotland • Any purpose for which the person carrying out the analysis has obtained the consent of a person with authority under specified provisions of the Adults with Incapacity (Scotland) Act 2000; • Purposes of a clinical trial authorised and carried out in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004; or • Surgical, medical, nursing, dental or psychological research permitted under section 51 of the Adults with Incapacity (Scotland) Act 2000. 122 Qualifying consent may be given to
analysis of DNA for any purpose by the person from whose body the material came. In the case of a living child 19, a person with parental responsibility (or in Scotland a person with parental responsibilities in relation to the child) may give qualifying consent on their behalf where no decision of the child to or not to consent is in force and either s/he is not competent to consent or though competent, chooses not to make that decision. After death, consent may be
given by anyone who stood in a qualifying relationship (see paragraph 53 above) with the deceased adult immediately before their death. In the case of a child, after death, consent may be given by a person with parental responsibility or where none, a person in a qualifying relationship immediately before they died. The ranking referred to in paragraph 53 does not apply in the case of qualifying consent for DNA analysis – it is sufficient that any person in a qualifying relationship gives consent. As the issue of paternity testing is a sensitive one, further guidance has been published by the Department of Health in this area. 123 The offence does not apply to ‘excepted’
material which is: • material from the body of a deceased person who died at least 100 years before commencement of section 45 of the Act; • an existing holding and the person holding it is not in, and is not likely to come into, possession of information from which the individual can be identified; or • an embryo outside the human body. There is also a defence that the person holding the material reasonably believes it to be ‘excepted’ material.
19 In its application to Scotland, a child for the purposes of this section is a person who has not attained the age of 16 years.
28
Powers of the court / the Human Tissue Authority to dispense with the need for consent 124 The HTA has the power to deem consent
to be in place for relevant material from someone who is untraceable, or who has not responded to requests for consent to use of his/her material, if that material could be used to provide information relevant to another person. This may be important where information could be obtained about the treatment and diagnosis of the applicant. The HTA will prepare procedures and issue guidance on the implementation of these provisions.
Requesting
125 Similarly, the Secretary of State can make
Regulations empowering a court to deem consent to be in place where relevant material or a body could be used for health-related research. It is envisaged that this power would be exercised only in rare and unusual cases where the research is in the public interest, for example, if a person had died of an unknown and potentially infectious virus. No such Regulations have yet been made.
29
Glossary These terms have been defined with reference to the Human Tissue Act and the HTA’s Codes of Practice and should be read in that context. Allogeneic use: Cells, tissue or organs 20 removed from one person and applied/transplanted into another. Altruistic non-directed donation A form of non-directed living donation, where an organ or part organ is donated by a healthy person who does not have a relationship with the recipient and who is not informed of whom the recipient will be.
Anonymisation: is a procedure to ensure that if relevant material is removed from a human body, all necessary steps are taken to prevent identifying the person from whose body the material has come. Appropriate consent: is defined in the Act by reference to the person who may give consent. Autologous use: Cells, tissue or organs removed from and applied/transplanted into the same person.
Requesting
Autopsy: A post-mortem examination. Anatomical examination: Macroscopic examination of the body of a deceased person, or separate parts of such a body, by dissection for anatomical purposes (teaching or studying, or researching into, the gross structure of the human body). Anatomical specimen: The body of a deceased person, including separated parts of such a body, to be used or in the course of being used for the purpose of anatomical examination. A former anatomical specimen is a deceased body, organ or body part donated for anatomical examination which is held once the examination of the rest of the body has been completed. Anatomist: An expert in anatomy. Anatomy: The science of the structure and organisation of the body and its parts.
20 Wherever the term ‘organ’ is referenced, this also includes ‘part organs’.
Biopsy: A procedure where tissue is removed from a living body for examination under a microscope. Cells: Individual human cells or a collection of human cells when not bound by any form of connective tissue. Clinical audit: A quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria. Stored tissue previously needed for diagnosis, for example, may need to be reviewed as part of this process. Clinical diagnosis: A process where a disease is identified from medical history-taking, diagnostic tests and physical examination.
30
Glossary Designated Individual: means the individual designated in the licence as the person under whose supervision the licensed activity is authorised to be carried on. This person is responsible for securing that other persons to whom the licence applies are suitable persons, that suitable practices are carried out in the course of carrying-on the licensed activity and for compliance with the conditions of the licence. The HTA must be satisfied as to the suitability of this person.
Requesting
Diagnosis: A process where a disease is identified by signs and symptoms, a history and laboratory tests. Directed donation: A form of donation where a healthy person donates an organ (usually a kidney) or part of an organ (for example liver or lung lobe) to a specific recipient. The recipient could be known to the donor (in the case of genetically or emotionally related donation) or unknown to the donor (in the case of paired / pooled donation).
Donation: The act of donating human tissue, cells or organs for a scheduled purpose. Donor: Every human source, whether living or deceased, of human tissue, cells or organs. Embryo: means a live human embryo where fertilisation is complete and includes an egg in the process of fertilisation. Ethical Approval: Defined under Regulations 21 made under Section 1(9) of the Act to mean approval given by a research ethics authority. Existing holdings: Body of a deceased person or relevant material which has come from a human body held immediately prior to the commencement of section 1 of the Human Tissue Act 2004 for use for a scheduled purpose. â&#x20AC;&#x2DC;Gillickâ&#x20AC;&#x2122; 22 competent (now also referred to as Fraser competent): A test of competence and method of determining the ability of a young person under the age of 16 to make decisions regarding their own healthcare.
DNA (deoxyribonucleic acid): the genetic material of humans which is located in the cell nucleus and controls heredity.
Haemopoietic: Relating to the production of blood cells.
Domino donation: When an organ is removed as part of a personâ&#x20AC;&#x2122;s treatment, it may be suitable for transplant into another person (e.g. a heart originally removed from the recipient of a heart and lung transplant).
Heart-beating donors: This refers to the circumstances where organs and tissue for transplantation are removed from donors fulfilling the nationally agreed and legally defined criteria of brainstem death.
21 The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006. 22 Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL).
31
Who can give consent? Human application: The use of tissue or cells on or in a human recipient. Independent Assessor: A person who acts as a trained and accredited representative of the HTA, to conduct an interview and prepare a report in circumstances envisaged under the Regulations 23, for some living organ donations for transplantation.
Requesting
JACIE: Joint Accreditation Committee – International Society for Cellular Therapy and European Group for Blood and Marrow Transplantation. Licensing: A number of activities can only be carried out where the establishment is licensed under the Act by the HTA for that purpose. The activities are: • the carrying out of an anatomical examination; • the making of a post-mortem examination; • the removal from the body of a deceased person (otherwise than in the course of the activities mentioned above) of relevant material of which the body consists or which it contains, for use for a Scheduled Purpose other than transplant; • the storage of an anatomical specimen; • the storage (other than of an anatomical specimen) of the body of a deceased person or relevant material which has come from a human body for use for a Scheduled Purpose; • the use, for the purpose of public display, of the body of a deceased person, or relevant material which has come from the body of a deceased person.
Licence Holder: The person who applies for and is granted a licence who can be, but is not necessarily the Designated Individual. The Licence Holder is responsible for the payment of any fees charged by the HTA including fees charged in respect of superintending compliance with licences and any other fees as specified by the HTA from time to time. The Licence Holder can be a corporate body. Where the applicant is not the proposed Designated Individual, the HTA must be satisfied that the applicant is a suitable person to be the holder of the licence. Licensed premises: Where the licensed activity (e.g. storage, or public display) takes place. If the licensed activity will take place at more than one place, a separate licence will need to be issued. Premises in different streets or with different postal codes will be considered as being in different places. In contrast, different buildings on a hospital site could be regarded as the same place. Living donors: The person donating tissue, cells or organs for transplantation. The most common forms are live kidney donation (where one kidney is removed), or live bone marrow donation. NHS Organ Donor Register: A confidential, computerised database managed by UK Transplant, which holds details of people who have signed up to become organ donors in the event of their death. The register is used after a person has died to help establish whether they wanted to donate and if so, which organs.
23 Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
32
Who can give consent? Non-directed donation: A form of donation where a person donates tissue, cells or organs an unknown recipient. Most commonly, this is deceased donation where the organ is allocated to the most suitable person on the transplant waiting list. Non-heartbeating donation: A form of donation in circumstances where the deceased donor was not ventilated at the time of death. Donation therefore occurs once death is certified following cardiorespiratory arrest (i.e. the donor’s heart has stopped beating).
Requesting
Organ: A differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy. Paired donation: Where a close relation, friend or partner is fit and able to donate an organ but is incompatible with the potential recipient, that couple can be matched to another couple in a similar situation, so that both people in need of a transplant receive a compatible organ. Peripheral blood stem cells: Cells found in the bloodstream which are able to differentiate into all the cell types found in the blood. Pooled donation: Where a close relation, friend or partner is fit and able to donate an organ but is incompatible with the potential recipient, that couple can be matched to other couples in a similar situation, so that
all people in need of a transplant receive a compatible organ. Post mortem: Dissection and examination of a body after death, principally in order to determine the cause of death or the presence of disease processes. A hospital post mortem examination is carried out with appropriate consent to gain a fuller understanding of the deceased person’s illness or the cause of death, and to enhance future medical care. Coroners’ post mortem examinations are carried out under the authority of the Coroner and without consent to assist Coroners in carrying out their functions. 24 Preservation: The use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissues. Processing: All operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications. Procurement: A process by which tissues or cells are made available. Public display: includes organised displays and exhibitions held in museums, galleries, exhibition venues and educational establishments, but not for the purpose of education or training. This definition is subject to change pending further consideration by the HTA.
24 Coroners’ post mortems are carried out in accordance with the provisions of the Coroner’s Act 1988 and the Coroner’s Rules 1984 (amended 2005) and the Coroners Act (Northern Ireland) 1959 and the Coroners (Practice and Procedure) Rules (Northern Ireland) 1963.
33
Who can give consent? Public health monitoring: Using populationbased or epidemiological techniques to ascertain the prevalence, spread and pattern of an established disease or condition in the community and relating its occurrence to public health programmes and activities.
Requesting
Quality assurance: A programme for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. Relevant material: is defined by the Act as material other than gametes, which consists of or includes human cells. In the Act, references to relevant material from a human body do not include: (a) embryos outside the human body, or (b) hair and nail from the body of a living person. Research: is concerned with creating new knowledge by addressing clearly defined questions with systematic and rigorous methods. It is about testing innovations or discovering the right thing to do e.g. finding out whether new treatments work and whether certain treatments or models of service delivery work better than others. Research forms the basis of nationally agreed clinical guidelines and standards and is designed to establish best practice. Research ethics authority: an ethics committee established or person appointed to advise on, or on matters which include, the ethics of research investigations on relevant material which has come from a human body.
Residual tissue: is material left over from a diagnostic or therapeutic intervention. Scheduled purposes: Scheduled Purposes are the activities relating to the removal, storage and use of human organs and other tissue, listed in Schedule 1 of the Act that require consent. The Purposes are divided into 2 parts: Part 1: Purposes Requiring Consent: General • Anatomical examination • Determining the cause of death • Establishing after a person’s death the efficacy of any drug or other treatment administered to him • Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person) • Public display • Research in connection with disorders, or the functioning, of the human body • Transplantation Part 2: Purposes Requiring Consent: Deceased persons • Clinical audit • Education or training relating to human health • Performance assessment • Public health monitoring • Quality assurance Serious adverse event: Any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissue and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, 34
Who can give consent? or which might result in, or prolong, hospitalisation or morbidity. Serious adverse reaction: An unintended response, including a communicable disease, in the donor or in the recipient, associated with the procurement or human application of tissue and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity. Stem cell: A precursor cell that can develop into more than one kind of cell. For example, early bone marrow cells can develop into red blood cells, white blood cells or platelets.
Requesting
Storage: Maintaining the tissue under appropriate controlled conditions. Surplus tissue: Relevant material which has come from a personâ&#x20AC;&#x2122;s body in the course of his receiving medical treatment, undergoing diagnostic testing, or participating in research.
Transplant coordinator: A person who helps a potential transplant recipient to understand the transplant process and also coordinates the transplant evaluation between the dialysis unit, transplant surgeon, and tissue typing laboratory. After a transplant, the nurse provides a communication link between the recipient and the transplant doctors for posttransplant care. Transplantable material: Defined under Regulations 25 made under Section 34 of the Act to mean the whole or part of any of the following organs if it is their function to be used for the same purpose as the entire organ in the human body: kidney, heart, lung or a lung lobe, pancreas, liver, bowel, larynx, face, or limb. Defined in the same Regulations under Section 33 of the Act to mean organs or part of an organ if it is to be used for the same purpose as the entire organ in the human body, bone marrow and peripheral blood stem cells.
Tissue: Any and all constituent part(s) of the human body formed by cells. Tissue establishment: A tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissue and cells are undertaken. It may also be responsible for procurement or testing of tissue and cells. Transplant: An implant of an organ, tissue or cells either from and into the same body or from one person to another.
25 The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
35
Background reading Learning from Bristol: the report of the public inquiry into children’s heart surgery at Bristol Royal Infirmary 1984-1995, Bristol Royal Infirmary, July 2001 Report of the Royal Liverpool Children’s Inquiry, January 2001
Requesting
Department of Health (May 2003) The investigation of events that followed the death of Cyril Mark Isaacs; Department of Health Isaacs Report Response, July 2003
36
Requesting
Human Tissue Authority Code of Practice â&#x20AC;&#x201C; Post mortem examination Code 3 July 2006
Contents Paragraphs
Requesting
Introduction
Paragraphs
Scope of the code
10–15
Information to be given to families after coroner’s and hospital post mortem
Patients who are dying
16–18
Results of the post mortem investigation
1–9
Post mortem examination (autopsy)
19–36
Quality standards
21–26
Coroner’s post mortem examination
27–34
Hospital post mortem
35–36
Who can give consent?
37–57
Appropriate consent – adults
39–41
Appropriate consent – children
42–46
Nominated representatives
47–49
Qualifying relationships
50–57
Discussing the post mortem with the family: who may seek consent?
58–83
What should the discussion cover?
70–80
Cultural traditions and language differences
81–83
Information about use of donated tissue and organs
Maintaining proper documentation Disposal of tissue and organs
84–94 84–93 94
95–99 100
Obtaining consent
101–109
Training and support for staff
110–113
Glossary
Introduction 1
Requesting
2
3
The Human Tissue Act 2004 (The Act) which extends to England, Wales and Northern Ireland only, sets out a new legal framework for the storage and use of tissue from the living and for the removal, storage and use of tissue and organs from the dead. This includes ‘residual’ tissue following clinical and diagnostic procedures. The Act repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they relate to England and Wales. It also repeals and replaces the Human Tissue Act (Northern Ireland) 1962, the Human Organ Transplants (Northern Ireland) Order 1989 and the Anatomy (Northern Ireland) Order 1992. There is separate legislation for Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA will perform certain tasks on behalf of the Scottish Executive. For the purpose of these codes, the term ‘NHS Trusts’ includes Health and Social Services (HSS) Trusts in Northern Ireland. The Act also establishes the Human Tissue Authority (HTA) as the regulatory body for all matters concerning the removal, storage, use and disposal of human tissue (excluding gametes and embryos) for scheduled purposes. This includes responsibility for living donor transplantation. This is one of the functions which the HTA will carry out on behalf of the Scottish Executive.
4
The HTA is also responsible for giving advice and guidance on the Act and for licensing establishments that carry out particular activities under the Act.
5
One of the HTA’s statutory functions is to issue codes of practice. This is one of the first six codes, which should be regarded as complementary: 1 Consent 2 Donation of organs, tissue and cells for transplantation 3 Post mortem examination 4 Anatomical examination 5 Removal, storage and disposal of human organs and tissue 6 Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation.
6
These codes give practical guidance to those carrying out activities which lie within the HTA’s remit and lay down the standards expected. These are not a definitive guide to the law and licence holders should refer to the Act and keep themselves informed about future legal developments.
7
The guidance given applies to anyone undertaking relevant activities. Failure to follow this guidance is not in itself a criminal offence under the Act, but the HTA may take any such breach into account when carrying out its responsibilities in respect of licensing.
3
Who can give consent? The codes have been approved by the Secretary of State and laid before Parliament in accordance with Section 29 of the Act.
9
Any references to the terms ‘tissue’, ‘organ’, ‘part organ’, ‘material,‘ ‘body parts’ or ‘cells’ in this code refers to ‘relevant material’. For definitions of terms used, please refer to the glossary at the back of this code.
Requesting
8
4
Scope of the code 10 This code updates and replaces Families
and post mortems: a code of practice issued by the Department of Health in April 2003 1. 11 Post mortem examination is crucially
important for informing relatives 2, clinicians and legal authorities about the cause of death. It can also inform bereaved people (should they wish to know) about possible acquired or genetic diseases which may need treatment and care. More generally, post mortem examination is important in improving clinical care, maintaining clinical standards, increasing our understanding of disease, preventing the spread of infectious diseases and in supporting research and training.
14 The code seeks to ensure that:
• those close to the deceased person are given the opportunity to understand the reasons for hospital and coroners’ post mortems, the processes involved, and their rights in the decision-making process • the wishes of the deceased person and those close to them are known and fully understood • organs and tissue are only retained following post mortem with consent or other lawful authorisation (such as that of the coroner) and • general information about post mortem examinations is readily accessible.
Requesting
15 The code does not deal with body parts or 12 Bereaved people should be treated with
respect and sensitivity at all times, both to help them take important decisions at a difficult time and to ensure continuing improvements in care. The standards expected when seeking and obtaining consent are touched on in this document, but set out in much greater detail in the HTA’s Code of practice on consent. 13 This code sets out recommended practice
for all those who communicate with relatives of children and adults who may undergo or have undergone a post mortem examination (whether or not ordered by the coroner). This also includes communication after pregnancy loss.
organs held for the purpose of anatomical examination. If the person who has died expressed a wish that their body should be used for anatomical purposes, it will not be possible to carry out that wish if the body has been subject to a post mortem examination or if any organs except the eyes have been removed for transplantation. (Carrying out a post mortem examination does not rule out organ donation for transplantation.) These exclusions may need to be explained to the deceased person’s relatives.
1 This code will also replace a Northern Ireland version of the code, ‘Post Mortem examinations – a code of good practice: rights of patients and relatives: responsibilities of professionals’ 2 Throughout this code, the term’ relatives’ should be taken to include close friends of the deceased person, in cases where there are no relatives
5
Patients who are dying 16 This code does not deal as such with the
support and information that hospitals should offer to dying patients 3. However, much of the decision-making after death is easier if patients have volunteered their wishes before death or already made the relevant decisions. This is a very sensitive matter that requires careful judgement in each case. 17 Where appropriate, hospitals should
Requesting
help dying patients and their relatives to understand what may happen immediately before and after death. While respecting the views of patients who indicate that they do not wish to discuss particular issues, clinicians should seek to ensure that: • any preferences about what happens immediately before or after a patient’s death are identified and understood by staff. Attitudes towards the use of tissue, and especially towards post mortems, can vary widely among cultures and religions. All healthcare professionals must be sensitive to this. However, each case and decision is an individual and personal one, and must be treated as such. • NHS Trusts and other establishments should ensure their employees are given the necessary training and support to help them identify and meet the widest possible range of needs and wishes • contact is made with a religious representative, if required
• any decisions of the dying person in respect of organ and tissue donation are recorded, and the relevant procedures understood, including post mortem examination • any discussions or preferences about the storage and use of organs or body parts for therapeutic purposes and for medical education or research are recorded, and • any wishes are recorded for the disposal of organs and tissue following post mortem examination, including those which may subsequently be used for medical education or research. 18 These points also apply to the persons
with parental responsibility of terminally ill children, or of babies dying in neonatal intensive care. Although raising these issues is highly sensitive, persons with parental responsibility need to be prepared for what is likely to happen immediately before and after their child’s death, and some will wish to discuss specific arrangements.
3 See Department of Health Advice: When a patient dies: advice on developing bereavement services in the NHS (www.dh.gov.uk/policyandguidance/healthandsocialcaretopics/bereavement/).
6
Post mortem examination (autopsy) 19 A post mortem examination (or autopsy)
may take place either because the coroner considers it necessary, or because it has been agreed upon by the deceased person or their relatives. This code lays down best practice for communication in both cases.
Requesting
20 In any setting (NHS, academic or other),
human tissue or organs may only be removed, stored, or used if appropriate consent has been obtained. Before the post mortem starts, the person obtaining consent should, in collaboration with the pathologist, check that the post mortem examination and any removal, storage or use have been properly authorised. This authorisation will either come from a completed consent form, which must meet the standards required by this code, or from the coroner. (This does not imply that pathologists should necessarily be the ones to seek consent, but they should be involved in the process).
Quality standards 21 All post mortems must be carried out
in premises licensed by the HTA, in accordance with the conditions of the licence. The person to whom the licence applies (the ‘Designated Individual 4’) has a duty to ensure that others carrying out the licensed activity (in this case conducting a post mortem examination) on the premises are suitable persons to do so, that suitable practices are being used
and that the conditions of the licence are being complied with. 22 The Royal College of Pathologists (RCPath)
has produced professional guidelines on autopsy practice which consolidate, update and expand on previous guidance. 5 Post mortem examination should follow these guidelines. 23 The RCPath guidelines indicate that the
removal and storage of tissue blocks and slides for the purposes of audit, teaching, quality assurance and review is normal good practice. The Act does not make any special exemptions from the consent requirements for storing blocks and slides. However, Regulations6 made by the Secretary of State exempt from licensing storage of relevant material from the body of a deceased person: • for use for research which is ethically approved by a Research Ethics Authority (or for which such approval is pending); and • for the sole purpose of analysis for a scheduled purpose (excluding research) where the material has come from, and is to be returned to, a licensed premises following analysis. 24 Therefore, whilst every effort should be
made to explain to those giving consent, that the storage of tissue blocks and slides may be essential to enable a diagnosis to be made and is valuable for review or
4 See Glossary 5 Guidelines on Autopsy Practice. Royal College of Pathologists 2005 (www.rcpath.org.uk) 6 The Human Tissue Act 2004 (Ethical Approval, Exceptions from licensing and Supply of Information about Transplants) Regulations 2006.
7
Who can give consent? audit purposes, specific consent must be obtained to store and/or use tissue (including blocks and slides) for any of the scheduled purposes listed in the Act. 7 25 Relatives may agree to a post mortem
examination being carried out to learn more about what caused the death, but may object to tissue being stored and/or used (including tissue blocks and slides). This may limit the usefulness of the post mortem and, if so, this should be explained to them. However, it should not prevent a post mortem being carried out unless the pathologist believes that the examination would be uninformative.
Requesting
26 Medical students, doctors and other
healthcare professionals may witness the post mortem examination or a demonstration of the findings for educational purposes and to develop their professional skills. This must also be explained to the deceased person’s relatives. All who witness the examination must respect the confidentiality of any information relating to the deceased person.
Coroner’s post mortem examination 27 Coroners’ post mortem examinations are
carried out to assist coroners in carrying out their functions.8 Although the consent of the deceased person or relatives is not
required, the reasons for the post mortem and the procedures to be followed should be explained sensitively to them. They should be given information about when and where the examination is to be performed and told of their right to be represented at the post mortem by a doctor, if they so wish. Whilst consent is not required for a Coroner’s post mortem, the carrying out of the post mortem will need to be licensed by the HTA when the Act comes fully into force. 28 Under revisions to the Coroner’s Rules
made in 2005,9 a coroner who orders a post mortem examination and is notified about the retention of organs or tissue for examination has a duty to inform the relatives or personal representative of the deceased person about the following before the post mortem is carried out: • that the material is being kept • the period or periods for which it needs to be kept • the options for dealing with the material once it is no longer required for the coroner’s purposes. These options are: • lawful disposal of the material by burial, cremation or other lawful means • return of the material to relatives to make their own arrangements, or • storage of the material with appropriate consent for use for medical research or other purposes.
7 See Glossary. 8 Coroners’ post mortems are carried out in accordance with the provisions of the Coroner’s Act 1988 and the Coroner’s Rules 1984 (amended 2005) and the Coroners Act (Northern Ireland) 1959 and the Coroners (Practice and Procedure) Rules (Northern Ireland) 1963. 9 www.opsi.gov.uk/si/si2005/20050420.htm. These Rules do not apply to Northern Ireland – the coroner does not have a duty to inform the relatives or personal representative of the deceased person how long the material is being kept; material is kept for such a period as the coroner thinks fit.
8
Who can give consent? 29 Further information about these latter
three options is set out in the Code of practice on removal, storage and disposal of human organs and tissue. 30 The deceased person’s relatives may
Requesting
wish to discuss the implications of these options, particularly the last two. A coroner’s officer10 or police officer will usually make contact with the bereaved in coroner’s cases, but relatives will need access to people with the appropriate knowledge to talk through any questions or concerns they may have. Local protocols between NHS Trusts and coroners’ offices should be developed, which are flexible enough to meet relatives’ needs.
is carried out, following the same practice for hospital post mortem examinations. However, this may be done retrospectively if time or distance does not permit otherwise or if the findings indicate an unforeseen reason for retention. 33 There is legal provision for a copy of
a coroner’s post mortem report to be provided to relatives for a fee. They should be told about this and told when the report will be available, and how to obtain a copy. (No charge is payable for a hospital post mortem report.) Unless the coroner has reason to do otherwise, a copy of the post mortem report should in any case be provided to the deceased person’s GP and relatives may wish to discuss the findings with them.
31 The most appropriate person to speak to
relatives about consent issues may vary depending on the nature of the case and their concerns – for example, if they have built up a close relationship with a particular staff member during the deceased person’s illness, that staff member may be best placed to discuss these issues. If there are genetic aspects to the deceased person’s illness that may affect future generations and make the retention of tissue highly desirable as a potential benefit to other family members, the specialist consultant might be asked to explain these aspects. 32 Ideally, a request for consent to eventual
retention of organs or tissue following completion of the coroner’s process should be made before the post mortem 10 In Northern Ireland, this is referred to as a Coroner’s Liaison Officer.
34 An inquest may also be necessary
following post mortem. If so, the reasons for the inquest and its procedures should be fully and sensitively explained to relatives. A coroner’s officer will usually do this.
Hospital post mortem 35 A hospital post mortem examination is
carried out, with the prior consent of the deceased person, the consent of their nominated representative or the consent of a person in a qualifying relationship (see paragraphs 50 - 55 below), to gain a fuller understanding of the deceased person’s illness or the cause of death and to enhance future medical care. During 9
Who can give consent? the post mortem examination, tissue or whole organs (e.g., the heart) may be preserved for diagnosis, therapeutic purposes, future medical education (including assuring the quality of clinical care through audit) or for research. If this happens, it must be in accordance with the provisions of the Act. The valid consent of relatives or those close to the deceased person must be given before the post mortem is undertaken to ensure proper compliance with the Act (unless the person who has died has already made a request â&#x20AC;&#x201C; see paragraphs 39â&#x20AC;&#x201C;41 below).
Requesting
36 The Act makes it unlawful to store or
use the body of a deceased person, or to remove, store or use any material from a deceased personâ&#x20AC;&#x2122;s body, for scheduled purposes without appropriate consent.
10
Who can give consent? 37 As noted above, consent must be
obtained for a hospital post mortem and for the removal, storage and use of organs and tissue for scheduled purposes after a hospital post mortem, or after the functions of the coroner have ended in relation to a coroner’s post mortem.
40 There is no legal obligation to obtain
consent from the immediate family or others in a qualifying relationship if proper consent from the deceased person (or their nominated representative) is in force. However, hospitals might prefer to discuss this with relatives (or whoever is acting as a person in a qualifying relationship).
38 The Act defines ‘appropriate consent’
differently, depending on whether the deceased person was a child or an adult. The following paragraphs should be read in conjunction with the Code of practice on consent.
Appropriate consent – adults Requesting
39 For activities other than public display or
anatomical examination (which are dealt with in the Code of practice on anatomical examination), ‘appropriate consent’ means: • the consent of the deceased person, if they gave or refused consent immediately before death; or, if this does not apply: • the consent of a nominated representative appointed by the deceased person to deal with this issue, or • if no nominated representative, then the consent of someone who stood in a ‘qualifying relationship’ to the deceased person immediately before that person died.
41 If the family or those close to the
deceased person object to the donation, for whatever purpose, when the deceased person (or their nominated representative – see below) has explicitly consented, clinicians should seek to discuss the matter sensitively with them. Relatives should be encouraged to accept the deceased person’s wishes and it should be made clear that they do not have the legal right to veto or overrule those wishes.
Appropriate consent – children 42 Under the Act, a child is defined as being
under 18 years old. 43 For activities other than public display or
anatomical examination (which are dealt with in the HTA’s Code of practice on anatomical examination), appropriate consent means the child’s consent if they are competent to do so. In the Gillick 11 case, the court held that a child is considered to be competent to give valid consent if they have sufficient intelligence and understanding to enable them fully to understand what is involved. In this context ‘appropriate consent’ means
11 Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL).
11
Who can give consent? the consent of the child; or, if they did not give or refuse consent immediately before death: • the consent of a person with parental responsibility for the child immediately before the child’s death, or • in the absence of a person with parental responsibility, the consent of a person in a ‘qualifying relationship’ to the child at that time (see paragraphs 50–55 below). A person who has parental responsibility will usually, but not always, be the child’s parent 12.
Requesting
44 If the child was in care, the local authority
may have had parental responsibility. However, even if the natural parents do not have that responsibility, they might reasonably expect to be consulted. Wherever practicable, discussion should be with both parents, and both should sign the consent form. If either parent is known to object, a post mortem examination should not be carried out.
deceased child has explicitly consented, clinicians should seek to discuss the matter sensitively with them. They should be encouraged to accept the deceased child’s wishes and it should be made clear that they do not have the legal right to veto or overrule those wishes.
Nominated representatives 47 Adults may appoint one or more persons
to represent them after their death in decisions about post mortem examination and the retention of organs and tissue. Where the deceased person’s wishes are not known, and a nominated representative has been appointed, this nominated representative is the person from whom you must seek consent. If someone comes forward as a nominated representative, their authority to act on the deceased person’s behalf must be verified, including what decisions they have the authority to make. The Act sets out the requirements for a valid appointment. The appointment of a nominated representative may be revoked at any time.
45 If proper consent from the deceased child
for a post mortem or the retention and/or use of organs and tissue for scheduled purposes has been obtained, hospital staff should discuss with the parents how they intend to proceed. 46 If the parents of the deceased child or
those close to the deceased child object to a post mortem examination when the
48 The appointment of a nominated
representative: • may be general, or limited to consent in relation to one or more activities • may be made orally (when it must be made in the presence of at least two witnesses present at the same time), or
12 The category of persons with parental responsibility is as set out in the Children Act 1989 as amended. Further guidance is available in the Department of Health’s Reference guide to consent for examination and treatment.
12
Who can give consent? • may be made in writing, when it must be: – signed in the presence of at least one witness who attests the signature, or – signed at the direction of the person making the appointment, in their presence and in the presence of at least one witness who attests the signature, or – contained in the deceased person’s will.
Requesting
49 If two or more people are appointed,
unless the terms of the appointment make it clear that they should act jointly, it should be assumed that they can act individually as well as jointly. The nomination may be disregarded if no-one is able to give consent under it, which includes where it is not reasonably practicable to communicate with the nominated representative within the time available if the consent is to be acted upon.
one of them, provided they are ranked equal highest). 51 The ‘ranking’ below is intended to
help those seeking consent to know who to approach, and in what order (highest first): a) spouse or partner (including civil or same sex partner) 13 b) parent or child c) brother or sister d) grandparent or grandchild e) niece or nephew f) stepfather or stepmother g) half-brother or half-sister h) friend of long standing. 52 Obtaining consent only makes the
activity lawful – it does not mean that it is obligatory. 53 Careful consideration should be given
Qualifying relationships 50 Where the deceased person has not made
a decision, and a nominated representative has not been appointed (or has been appointed but the nomination has been disregarded in accordance with paragraph 49), the Act ranks persons in a ‘qualifying relationship’ in the order set out below. Consent should be obtained from the person ranked highest. (Relationships listed together, for example ‘brother or sister’, are accorded equal ranking, in which case it is sufficient to obtain consent from just
before proceeding on the basis of one person’s consent if there are overwhelmingly strong objections. For example, if a spouse or partner has no objections to organs or tissue being used for research, but everyone else in the family strongly objects, going ahead may well do more harm than good.
13 Section 54 (8) of the Act states that for these purposes a person is another person’s partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship.
13
Who can give consent? 54 Where there are differences of opinion
Requesting
between people in qualifying relationships, decisions will need to be made on a caseby-case basis, taking into account: • The views of the highest-ranking person in a qualifying relationship – if, for example, a spouse or partner refuses consent, then that should take precedence even if other family members object to that decision and would give consent. • The views of other qualifying relatives – if, for example, a spouse consents to use for research but other family members strongly object, the benefits of carrying out the activity should be weighed against the distress and resentment that could be caused by proceeding in the face of strong opposition. This will be especially sensitive where people in equally ranked qualifying relationships disagree. • The potential benefit to other family members – if, for example, two siblings disagree on whether or not material should be retained, potential benefits to family members (e.g., where genetic information may be of value), make a stronger case for going ahead than where such factors do not apply. 55 An agreed position should be reached
by inclusive discussion where possible. This will need careful explanations of the options and the potential benefits of a post mortem and of the retention of organs or tissue. Whilst it may be legally
possible to carry out activities with the consent of the highest-ranking qualifying person, consideration should be given to the possibility of this causing distress and resentment in other family members. 56 Although the Act only applies to live
births, it is good practice for consent to be obtained from the mother in case of pregnancy loss regardless of gestational age 57 Asking parents to agree to a post mortem
examination of their baby or young child is particularly difficult. The Stillbirth and Neonatal Death Society (SANDS) has published specific and detailed guidance for healthcare professionals on managing pregnancy loss and the death of a baby. 14 The Department of Health video Respect for the dead; care for the living is also a useful aid when discussing this topic.
Discussing the post mortem with the family: who may seek consent? 58 The way in which a post mortem
examination is discussed with the deceased person’s relatives or close friends is extremely important. They need to be given: • honest, clear, objective information • the opportunity to talk to someone they can trust, and of whom they feel able to ask questions • reasonable time to reach decisions (about a hospital post mortem and
14 Pregnancy loss and the death of a baby: guidelines for professionals. Nancy Kohner and Alix Henley, SANDS, 1995. Northern Ireland has also produced guidance on this topic: ‘Careplan for Women who experience a miscarriage, stillbirth or neonatal death’.
14
Who can give consent? about any donation of organs or tissue); privacy for discussion between family members, if applicable and • support if they need and want it, including the possibility of further advice or bereavement counselling, or psychological support. (Support may be available from an organisation with whom a relative is already in touch, particularly if they have been a longterm carer of the deceased person.)
for contacting the coordination service or otherwise seeking advice. 62 Those seeking consent for hospital post
mortem examinations should be sufficiently senior and well informed, with a thorough knowledge of the procedure. They should have been trained in the management of bereavement and in the purpose and procedures of post mortem examinations. 63 It is usually the responsibility of the
59 Only once relatives have had time to
reach a decision should they be invited to sign a consent form.
Requesting
60 Many people have registered on the NHS
Organ Donor Register or carry an organ donor card. The deceased person’s relatives may be aware of their wishes about donation of organs or tissue for transplantation and may raise this possibility. Discussion about donation should have taken place in the hospital, and relatives may have decided to donate if possible. All efforts should be made to allow those who wish to donate organs or tissue to do so and explanations should be given where it is not possible. 61 Where organ or tissue donation is a
possibility (and it should be made clear that this will involve storing tissue until it can be used), the staff member talking to the deceased person’s relatives should make early contact with the local transplant coordinator for advice. There may be local variations, but every hospital should have clear arrangements in place
deceased person’s clinician to seek consent, knowing the medical problems and the unresolved aspects that merit investigation. However, there may be several options for who actually discusses the post mortem and obtains consent, and most will involve a team approach. Every hospital must have an effective and reliable procedure in place. Responsibility for obtaining consent should not be delegated to untrained or inexperienced staff. 64 In some hospitals, an appropriately
trained individual undertakes the role, with input from the consultant. In others, it may be the consultant or other senior clinician in charge during the patient’s last illness, or someone who has been closely involved with the case or has practical experience of such situations. Nurses and midwives may be trained to take on this particular role. 65 Wherever possible, consent is best
obtained by a person with whom the relatives have established a relationship. If the consultant in charge has not had close 15
Who can give consent? dealings with the patientâ&#x20AC;&#x2122;s family during the last illness, relatives may find it helpful to also have someone present whom they know and trust. However, if a patient has died suddenly, there may be nobody who knows the family. 66 Whichever approach is taken, the hospital
should have a named individual who can provide support and information to the bereaved if a post mortem examination is required, whether this is requested by a hospital doctor or a coroner. In some hospitals, this person may also be the one responsible for asking for consent (see paragraph 65 above).
Requesting
67 Wherever possible, before the discussion
with relatives, the responsible clinician should contact the pathologist who will perform the post mortem examination. They can then give accurate guidance on which, if any, tissue or organs are likely to be retained, for how long and for what purpose. The pathologist should also be available for a discussion with the deceased personâ&#x20AC;&#x2122;s relatives if they wish. If the pathologist is certain that no organs will be retained, then there will be no need to ask relatives to consent to this, and the relevant section of the consent form may be deleted. 68 Meetings about the post mortem,
including its timing, should take place in a comfortable, private room, away from the clinical area. This is a complex issue and discussions with bereaved relatives should be face-to-face if possible, so that they do
not have any unanswered questions, and all parties are clear about what is agreed. 69 If a face-to-face meeting is impossible
because relatives cannot attend, consent to a post mortem examination can be given over the phone or by e-mail. The telephone conversation should be accurately recorded and a copy of the consent form and other relevant documentation given to the relative, just as in a face-to-face meeting. Pathologists should satisfy themselves that the consent was appropriate before proceeding with a post mortem examination.
What should the discussion cover? 70 Relatives should be offered full and clear
information about the purpose of the post mortem examination, the procedures and the range of choices available to them. They may need time to think this over. The cells and tissue of the body deteriorate after death, so if time is short, for example, because an early post mortem will obtain more or better information, relatives should be told what the time limits are and the reasons for them. 71 Factual information should be provided in
a permanent form so relatives can take it away with them. At the end of the meeting, they should be provided with a permanent record of the discussion, and of the agreement reached. A signed copy should be included in the patient record and/or coronerâ&#x20AC;&#x2122;s file as appropriate. 16
Who can give consent? 72 If possible, relatives should be given the
option of changing their minds, within an agreed time limit. They should be provided with the name, telephone number and/or e-mail address of the hospital’s designated bereavement adviser or equivalent, so they can ask further questions later. Ready access to general explanatory material – e.g., a hospital website – may also be helpful. 73 When discussing the post mortem, some
Requesting
people will want to know in considerable detail what will be done to the body. In such cases the procedure should be sensitively, but honestly and fully, explained. Others will not want as much or even any detail. This should be respected. 74 The discussion should include:
• a basic explanation of what happens in a post mortem examination (including the removal, storage and use of tissue samples for diagnosis) • the benefits of a post mortem examination and the questions to be addressed in this case, and/or the reasons for the coroner’s involvement • the possible outcome • possible alternatives to a full post mortem examination (making clear the limitations to these, and the benefits of a full post mortem) • information about tests needed (e.g. histology, toxicology) and whether these might cause delays in the process
• when, to whom and how the results of the investigation will be made available and explained • options for what will happen to the body or remains, and any organs or tissue removed (including tissue blocks and slides), after the examination • whether consent is to be given for storage or use of tissue or organs after the post mortem and for what purposes • an explanation of the need for any images to be made (including photographs, slides, X-rays and CT scans) and of their use. In accordance with General Medical Council guidance, consent is not needed for the taking of photographs of organs, body parts, or pathology slides. Nor is consent needed to use images for any purpose provided that the images are effectively anonymised before use by the removal of any identifying marks • whether organs or tissue can be retained indefinitely for medical research, and whether there are particular uses which relatives would wish to exclude from any general consent given and • the timing of burial or cremation so that, where possible, any human material removed can be reunited with the body for burial or cremation, if relatives so wish. This will need to be done in consultation with the pathologist, and in the case of a coroner’s post mortem, with the coroner.
17
Who can give consent? 75 In some religions (including the Jewish,
Muslim and Hindu faiths), it is important that a funeral should take place as soon as possible. In such cases, every effort should be made to carry out a post mortem examination as quickly as possible (if one is required). The views of relatives should be sought on what constitutes a reasonable timeframe. If this is not likely to be practicable, or if organs cannot be returned within that period, this should be explained to relatives. They will need the help of hospital staff to get the necessary certification completed urgently before the funeral.
78 Consent to the post mortem must be
separate from consent to the subsequent removal, storage and use of tissue and organs (including blocks and slides) – i.e. relatives must be clear that these are two separate decisions. Whenever possible relatives should be asked before a coroner’s post mortem takes place whether they might agree to the subsequent storage of removed tissue and organs and their use for certain scheduled purposes once the cause of death has been established and the coroner’s duties are complete. 79 The discussion must make clear to relatives:
Requesting
76 In the case of a coroner’s post mortem,
relatives do not have the option of refusal, but may want to discuss the implications of any consequent delay with the coroner’s staff. 77 The pathologist conducting a consented
post mortem examination may feel that the conditions imposed by relatives call into question or limit the value of the post mortem, or make it difficult for them to carry out a post mortem to a proper professional standard. In such cases, the pathologist should advise relatives of these limitations or, if necessary, that the investigation will not be carried out because it would be uninformative. This eventuality should be explained to relatives at the time of discussion. However, pressure must not be exerted on them as this would render invalid any consent given.
• the meaning of the term ‘human tissue’; i.e. it includes organs, parts of organs and tissue in various forms, such as frozen sections and samples fixed in paraffin wax • the various purposes for which tissue might be kept and • their options for giving or refusing consent to storage of any particular organ or tissue, and for any particular use. 80 Although healthcare professionals may
recognise the need to obtain a speedy decision in order to maximise the benefit from a post mortem examination, it is important that they do not convey to relatives any sense of being rushed. Before the post mortem, relatives may want to spend as much time as possible with the family member who has died and it is important to try to ensure that they have this time. However, if more information 18
Who can give consent? or better results might be obtained from an early examination, then this should be explained.
Cultural traditions and language differences 81 Attitudes to post mortem examination,
burial, and the use of organs and tissues after death differ greatly. The person providing bereavement support must be fully informed about the values and beliefs of a wide range of cultures and religions, particularly those of their local community.
Requesting
82 All healthcare professionals need to be
aware of these values and respond to them sensitively. NHS Trusts must ensure that staff are given the necessary training and support to identify and meet the widest possible range of needs and wishes. Bereaved relatives may not always know what is traditional or customary within the community when a death occurs and may wish for time to talk to other family and community members. However, each case and decision is an individual and personal one, and must be treated as such. 83 Valid consent can only be given if proper
communication takes place. All NHS Trusts must consider the needs of people whose first language is not English or who have communication difficulties. They should ensure that such people have access to appropriate materials and support â&#x20AC;&#x201C; independent translators, for example â&#x20AC;&#x201C; so they can understand and participate in any discussions. 19
Information to be given to relatives after coroner’s and hospital post mortem Results of the post mortem investigation 84 There may be occasions where the
deceased person expressed a specific wish before death that information should not be shared with relatives and this should be respected. The results of a coroner’s post mortem examination can only be given with the permission of the coroner.
Requesting
85 Before any post mortem is carried out,
relatives should be told when the results are likely to be available. For a hospital post mortem (and for any post mortem on a baby or child), they should be given an appointment (if they want one) that will allow them to discuss the results with the clinician responsible for the deceased person’s care and/or the pathologist or other specialist clinician, where that would be helpful.
88 If a coroner orders a post mortem, it is
to identify the cause and circumstances of death, and it should be explained to relatives that the results may be limited in scope. If they want fuller information from a coroner’s post mortem, this might be agreed and the necessary consents recorded in advance. 89 The coroner should be consulted before
information about the examination, or any copy of the report, is made available to anyone. If the death is still subject to an inquest, any such discussion may be inappropriate and should happen only with the coroner’s agreement. Relatives should be warned of this eventuality in advance wherever possible. Coroner’s Rules regulate access to the post mortem reports provided for coroners, and a fee may be payable for a copy of a report. 90 In the case of a full hospital post mortem
86 Relatives will usually be anxious to receive
the results of the investigation. They will be better able to tolerate any delay if they understand the reasons for it. Hospitals will need to plan for the resource implications of this if it has not been standard practice to date. It is essential that discussion between the clinician and the pathologist takes place before such information is given to bereaved relatives. 87 Some relatives will not want to know the
results of the post mortem, or will not want to discuss them in detail. Their wishes must be respected. However, they should be offered the opportunity to discuss the results at a later date.
examination, the results meeting should allow for as wide a discussion as the relatives want. Although in general information about deceased patients should be treated in confidence, in these circumstances the relatives’ legitimate wish for relevant information should be met with proper care and sensitivity, subject to any expressed wishes of the deceased person. 91 For parents who have suffered pregnancy
loss or the death of a baby, the pathology results may raise many issues which it is important for them to discuss as a couple. These issues may require further discussion with other healthcare professionals, such 20
Who can give consent? as a genetic specialist. Parents should be offered the chance to have such a meeting. If they do not feel ready to take up that offer immediately, they should be provided with written contact details so that they can get in touch again at a later date. They should also be told who to contact (and how) if they have questions later on and given details of national and local support agencies. 92 With the coroner’s permission where
Requesting
required, the parents of a child who has died should be offered a copy of the full pathologist’s report. They should be helped to prepare for what such a report may include and a relevant clinician should help them to understand it. This may be appropriate for adult deaths too.
Information about use of donated tissue and organs 94 If relatives have given consent to tissue
and organs being stored and used after the post mortem, they should be asked if they wish to receive generalised information about the likely use. If tissue may be used for teaching, a leaflet on the value of medical education and the contribution of organs and tissue may be appropriate. The HTA’s Code of practice on removal, storage and disposal of human organs and tissue discusses this in more detail.
93 Subject to the parents’ agreeing, the
report should also be given to the deceased child’s GP and/or treating clinician and to the mother’s GP in the case of a neonatal death or stillbirth.
21
Maintaining proper documentation 95 Establishments should ensure that systems
are in place to maintain proper records and documentation for all tissue and organs they acquire and/or pass on to others. The Designated Individual named in licences issued by the HTA must ensure that such systems are in place. 96 It is important to be able to track what
happens to organs and tissue for health and safety reasons – for example, should an infection related to the material occur, resulting in the need to trace people who came into contact with it. Keeping proper records of what happens to donated material also demonstrates proper respect for the donation.
Requesting
97 The duty to create and maintain proper
records starts with the establishment where the material is removed from the body. Such initial records should include details of:
98 Of course, tissue may be transferred from
one place to another many times. In order to be able to maintain an audit trail, each establishment that handles human organs or tissue must have systems that can record: • when the material was acquired and from where • the uses to which the material is put whilst under the responsibility of the establishment concerned and any processes applied to it and • when the material is transferred elsewhere, and to whom. 99 European Directive 2004/23/EC which
comes into force in April 2006 requires that adequate systems be set up to ensure the traceability of human tissue and cells intended for human application. The Directive will be transposed into law by Regulations.
• who gave consent • exactly what the consent related to and any restrictions on use stipulated during the consent process • what processes are applied to the tissue • if tissue is transferred, when and to whom and • if relevant, when and how disposal is undertaken.
22
Disposal of tissue and organs 100 Guidance on disposal is available in the
Requesting
Code of practice on the removal, storage and disposal of human organs and tissue.
23
Obtaining consent 101 The validity of consent does not depend
on the form in which it is given. The information required and the manner in which the consent is taken and recorded can vary depending on the particular circumstances. 102 For consent to be valid it must be given
voluntarily by an appropriately informed person who has the capacity to agree to the activity in question. Written consent merely serves as evidence of consent. If it was not given voluntarily by a person with the capacity to do so and with appropriate information, a signature on a form would not make the consent valid.
arrangements in place in order to meet their particular needs. For example, an NHS Trust with a specialist research unit attached to it may well wish to specifically explore the possibility of donation for particular research projects. Consent forms for donation for specific projects require ethical approval15. 105 Establishments should design consent
forms to suit their own local needs and arrangements. However, the forms should show that at least the issues described in paragraph 74 have been discussed with relatives, and that they understand exactly what they are consenting to. Model consent forms will be available on the HTAâ&#x20AC;&#x2122;s website16.
Requesting
103 Consent may be expressed verbally or
non-verbally. An example of non-verbal consent would be where a person, after receiving appropriate information, holds out an arm for blood to be taken. Where consent is obtained for future storage or use of samples, but the consent itself is not a written consent, it is important to keep an appropriate record of the fact that consent has been given and for what purpose(s). This might be noted in the patient record, the laboratory records, or both. 104 Whilst there is a need for consistently high
standards of communication and recordkeeping in discussing and obtaining consent, it is recognised that individual establishments will have different
106 Establishments should make information
available in a variety of ways (leaflets, videos, DVDs, etc.) to help people understand what a post mortem entails and why consent is being sought. 107 The HTAâ&#x20AC;&#x2122;s Code of practice on consent
gives more detailed guidance on obtaining consent â&#x20AC;&#x201C; including consent for post mortem examination. It emphasises that consent should be seen as part of a process in which individuals, families, or others who are involved in decisionmaking have an opportunity to listen, discuss, ask questions, understand and choose.
15 Defined under Regulations 2006 (The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) to mean approval given by a research ethics authority. 16 In Northern Ireland, HSS Trusts and other relevant organisations should use the standardised consent forms agreed with the DHSSPS.
24
Who can give consent? 108 The guidance in the code is based on
these key principles: • as a first step, a willingness to discuss the question of consent should be established • full information about the consent process should be provided where possible and in a variety of formats • consent must be based on an understanding of what the procedure involves • consent need not be given in writing to be appropriate and informed • consent should ideally be generic.
Requesting
109 It goes on to stress that the way in which
the options are discussed with the deceased person’s relatives is extremely important. As well as being approached with sensitivity, they should be given: • honest, clear, objective information • the opportunity to talk to someone they can trust, and of whom they feel able to ask questions • reasonable time to reach decisions (about a hospital post mortem and about any donation of organs or tissue) • privacy for discussion between family members, if applicable and • support if they need and want it, including the possibility of further advice or psychological support.
25
Training and support for staff 110 Training in effective communication and
interpersonal skills is important for the successful implementation of most aspects of this code and to enable clinical and other staff to manage bereavement well. 111 The development of local joint protocols
between health establishments and the coroner may provide opportunities for considering training needs and opportunities in the round, in liaison with the relevant bodies such as the police and local authority.
Requesting
112 The death of a patient may be distressing
113 Important elements to consider are:
• a supportive working environment and a team or organisational culture in which the impact of loss, and the need for support, are acknowledged • opportunities for case review and debriefing • access to confidential, non-managerial support and • training, so that staff are equipped to manage bereavement and loss and to handle questions on difficult issues that relatives may understandably wish to raise.
not only for relatives, but also for members of the clinical team involved in that patient’s care. Their needs should be considered when bereavement services are planned, in training staff in procedures for obtaining consent for post mortem examinations, and in providing support at the time of death.
26
Glossary These terms have been defined with reference to the Human Tissue Act and the HTA’s Codes of Practice and should be read in that context. Allogeneic use: Cells, tissue or organs 17 removed from one person and applied/transplanted into another. Altruistic non-directed donation A form of non-directed living donation, where an organ or part organ is donated by a healthy person who does not have a relationship with the recipient and who is not informed of whom the recipient will be.
Anonymisation: is a procedure to ensure that if relevant material is removed from a human body, all necessary steps are taken to prevent identifying the person from whose body the material has come. Appropriate consent: is defined in the Act by reference to the person who may give consent. Autologous use: Cells, tissue or organs removed from and applied/transplanted into the same person.
Requesting
Autopsy: A post-mortem examination. Anatomical examination: Macroscopic examination of the body of a deceased person, or separate parts of such a body, by dissection for anatomical purposes (teaching or studying, or researching into, the gross structure of the human body). Anatomical specimen: The body of a deceased person, including separated parts of such a body, to be used or in the course of being used for the purpose of anatomical examination. A former anatomical specimen is a deceased body, organ or body part donated for anatomical examination which is held once the examination of the rest of the body has been completed. Anatomist: An expert in anatomy. Anatomy: The science of the structure and organisation of the body and its parts.
17 Wherever the term ‘organ’ is referenced, this also includes ‘part organs’.
Biopsy: A procedure where tissue is removed from a living body for examination under a microscope. Cells: Individual human cells or a collection of human cells when not bound by any form of connective tissue. Clinical audit: A quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria. Stored tissue previously needed for diagnosis, for example, may need to be reviewed as part of this process. Clinical diagnosis: A process where a disease is identified from medical history-taking, diagnostic tests and physical examination.
27
Who can give consent? Designated Individual: means the individual designated in the licence as the person under whose supervision the licensed activity is authorised to be carried on. This person is responsible for securing that other persons to whom the licence applies are suitable persons, that suitable practices are carried out in the course of carrying-on the licensed activity and for compliance with the conditions of the licence. The HTA must be satisfied as to the suitability of this person.
Requesting
Diagnosis: A process where a disease is identified by signs and symptoms, a history and laboratory tests. Directed donation: A form of donation where a healthy person donates an organ (usually a kidney) or part of an organ (for example liver or lung lobe) to a specific recipient. The recipient could be known to the donor (in the case of genetically or emotionally related donation) or unknown to the donor (in the case of paired / pooled donation).
Donation: The act of donating human tissue, cells or organs for a scheduled purpose. Donor: Every human source, whether living or deceased, of human tissue, cells or organs. Embryo: means a live human embryo where fertilisation is complete and includes an egg in the process of fertilisation. Ethical Approval: Defined under Regulations 18 made under Section 1(9) of the Act to mean approval given by a research ethics authority. Existing holdings: Body of a deceased person or relevant material which has come from a human body held immediately prior to the commencement of section 1 of the Human Tissue Act 2004 for use for a scheduled purpose. â&#x20AC;&#x2DC;Gillickâ&#x20AC;&#x2122; 19 competent (now also referred to as Fraser competent): A test of competence and method of determining the ability of a young person under the age of 16 to make decisions regarding their own healthcare.
DNA (deoxyribonucleic acid): the genetic material of humans which is located in the cell nucleus and controls heredity.
Haemopoietic: Relating to the production of blood cells.
Domino donation: When an organ is removed as part of a personâ&#x20AC;&#x2122;s treatment, it may be suitable for transplant into another person (e.g. a heart originally removed from the recipient of a heart and lung transplant).
Heart-beating donors: This refers to the circumstances where organs and tissue for transplantation are removed from donors fulfilling the nationally agreed and legally defined criteria of brainstem death.
18 The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006. 19 Gillick v West Norfolk and Wisbech Area Health Authority [1985] 3 All ER 402 (HL).
28
Who can give consent? Human application: The use of tissue or cells on or in a human recipient. Independent Assessor: A person who acts as a trained and accredited representative of the HTA, to conduct an interview and prepare a report in circumstances envisaged under the Regulations 20, for some living organ donations for transplantation.
Requesting
JACIE: Joint Accreditation Committee – International Society for Cellular Therapy and European Group for Blood and Marrow Transplantation. Licensing: A number of activities can only be carried out where the establishment is licensed under the Act by the HTA for that purpose. The activities are: • the carrying out of an anatomical examination; • the making of a post-mortem examination; • the removal from the body of a deceased person (otherwise than in the course of the activities mentioned above) of relevant material of which the body consists or which it contains, for use for a Scheduled Purpose other than transplant; • the storage of an anatomical specimen; • the storage (other than of an anatomical specimen) of the body of a deceased person or relevant material which has come from a human body for use for a Scheduled Purpose; • the use, for the purpose of public display, of the body of a deceased person, or relevant material which has come from the body of a deceased person.
Licence Holder: The person who applies for and is granted a licence who can be, but is not necessarily the Designated Individual. The Licence Holder is responsible for the payment of any fees charged by the HTA including fees charged in respect of superintending compliance with licences and any other fees as specified by the HTA from time to time. The Licence Holder can be a corporate body. Where the applicant is not the proposed Designated Individual, the HTA must be satisfied that the applicant is a suitable person to be the holder of the licence. Licensed premises: Where the licensed activity (e.g. storage, or public display) takes place. If the licensed activity will take place at more than one place, a separate licence will need to be issued. Premises in different streets or with different postal codes will be considered as being in different places. In contrast, different buildings on a hospital site could be regarded as the same place. Living donors: The person donating tissue, cells or organs for transplantation. The most common forms are live kidney donation (where one kidney is removed), or live bone marrow donation. NHS Organ Donor Register: A confidential, computerised database managed by UK Transplant, which holds details of people who have signed up to become organ donors in the event of their death. The register is used after a person has died to help establish whether they wanted to donate and if so, which organs.
20 Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
29
Who can give consent? Non-directed donation: A form of donation where a person donates tissue, cells or organs an unknown recipient. Most commonly, this is deceased donation where the organ is allocated to the most suitable person on the transplant waiting list. Non-heartbeating donation: A form of donation in circumstances where the deceased donor was not ventilated at the time of death. Donation therefore occurs once death is certified following cardiorespiratory arrest (i.e. the donor’s heart has stopped beating).
Requesting
Organ: A differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy. Paired donation: Where a close relation, friend or partner is fit and able to donate an organ but is incompatible with the potential recipient, that couple can be matched to another couple in a similar situation, so that both people in need of a transplant receive a compatible organ. Peripheral blood stem cells: Cells found in the bloodstream which are able to differentiate into all the cell types found in the blood. Pooled donation: Where a close relation, friend or partner is fit and able to donate an organ but is incompatible with the potential recipient, that couple can be matched to other couples in a similar situation, so that
all people in need of a transplant receive a compatible organ. Post mortem: Dissection and examination of a body after death, principally in order to determine the cause of death or the presence of disease processes. A hospital post mortem examination is carried out with appropriate consent to gain a fuller understanding of the deceased person’s illness or the cause of death, and to enhance future medical care. Coroners’ post mortem examinations are carried out under the authority of the Coroner and without consent to assist Coroners in carrying out their functions. 21 Preservation: The use of chemical agents, alterations in environmental conditions or other means during processing to prevent or retard biological or physical deterioration of cells or tissues. Processing: All operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications. Procurement: A process by which tissues or cells are made available. Public display: includes organised displays and exhibitions held in museums, galleries, exhibition venues and educational establishments, but not for the purpose of education or training. This definition is subject to change pending further consideration by the HTA.
21 Coroners’ post mortems are carried out in accordance with the provisions of the Coroner’s Act 1988 and the Coroner’s Rules 1984 (amended 2005) and the Coroners Act (Northern Ireland) 1959 and the Coroners (Practice and Procedure) Rules (Northern Ireland) 1963.
30
Who can give consent? Public health monitoring: Using populationbased or epidemiological techniques to ascertain the prevalence, spread and pattern of an established disease or condition in the community and relating its occurrence to public health programmes and activities.
Requesting
Quality assurance: A programme for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. Relevant material: is defined by the Act as material other than gametes, which consists of or includes human cells. In the Act, references to relevant material from a human body do not include: (a) embryos outside the human body, or (b) hair and nail from the body of a living person. Research: is concerned with creating new knowledge by addressing clearly defined questions with systematic and rigorous methods. It is about testing innovations or discovering the right thing to do e.g. finding out whether new treatments work and whether certain treatments or models of service delivery work better than others. Research forms the basis of nationally agreed clinical guidelines and standards and is designed to establish best practice. Research ethics authority: an ethics committee established or person appointed to advise on, or on matters which include, the ethics of research investigations on relevant material which has come from a human body.
Residual tissue: is material left over from a diagnostic or therapeutic intervention. Scheduled purposes: Scheduled Purposes are the activities relating to the removal, storage and use of human organs and other tissue, listed in Schedule 1 of the Act that require consent. The Purposes are divided into 2 parts: Part 1: Purposes Requiring Consent: General • Anatomical examination • Determining the cause of death • Establishing after a person’s death the efficacy of any drug or other treatment administered to him • Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person) • Public display • Research in connection with disorders, or the functioning, of the human body • Transplantation Part 2: Purposes Requiring Consent: Deceased persons • Clinical audit • Education or training relating to human health • Performance assessment • Public health monitoring • Quality assurance Serious adverse event: Any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissue and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, 31
Who can give consent? or which might result in, or prolong, hospitalisation or morbidity. Serious adverse reaction: An unintended response, including a communicable disease, in the donor or in the recipient, associated with the procurement or human application of tissue and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity. Stem cell: A precursor cell that can develop into more than one kind of cell. For example, early bone marrow cells can develop into red blood cells, white blood cells or platelets.
Requesting
Storage: Maintaining the tissue under appropriate controlled conditions. Surplus tissue: Relevant material which has come from a personâ&#x20AC;&#x2122;s body in the course of his receiving medical treatment, undergoing diagnostic testing, or participating in research.
Transplant coordinator: A person who helps a potential transplant recipient to understand the transplant process and also coordinates the transplant evaluation between the dialysis unit, transplant surgeon, and tissue typing laboratory. After a transplant, the nurse provides a communication link between the recipient and the transplant doctors for posttransplant care. Transplantable material: Defined under Regulations 22 made under Section 34 of the Act to mean the whole or part of any of the following organs if it is their function to be used for the same purpose as the entire organ in the human body: kidney, heart, lung or a lung lobe, pancreas, liver, bowel, larynx, face, or limb. Defined in the same Regulations under Section 33 of the Act to mean organs or part of an organ if it is to be used for the same purpose as the entire organ in the human body, bone marrow and peripheral blood stem cells.
Tissue: Any and all constituent part(s) of the human body formed by cells. Tissue establishment: A tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissue and cells are undertaken. It may also be responsible for procurement or testing of tissue and cells. Transplant: An implant of an organ, tissue or cells either from and into the same body or from one person to another.
22 The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006.
32
Background reading Learning from Bristol: the report of the public inquiry into children’s heart surgery at Bristol Royal Infirmary 1984-1995, Bristol Royal Infirmary, July 2001 Report of the Royal Liverpool Children’s Inquiry, January 2001
Requesting
Department of Health (May 2003) The investigation of events that followed the death of Cyril Mark Isaacs; Department of Health Isaacs Report Response, July 2003
33
Tests
Tests
Test Information Profiles
This section contains information about the tests that the laboratory performs, what samples are required and how to transport and store the samples
Directorate of Pathology Pathology Tests This section covers the tests that the Pathology Directorate offers. The laboratory performs many tests which are grouped into sets which performed together. Examples include the Full Blood Count (FBC) or a Liver Function Test (LFT). This is the usual method for requesting these tests. Within this section all tests are referred to via their common requesting set, and within each set description, the individual test components are detailed – These are the elements of the requesting set that are reported. Certain tests are also requested individually. If you cannot find the test from the index list, then the test can be retrieved using a free text search on the handbook using the functionality built into Acrobat (Click the Find button on this page). Information Available For each test the following items of information are supplied within these pages. • Department performing the test • Contact Telephone numbers for enquiry and advice • Which sample containers are required • Which request form should be used • What specimen is required for the test • When the test is available • Comments on the use of this test • If there are any special storage requirements • How long the sample is stable for prior to laboratory testing • Special Requirements for the performing of this test Reference Ranges Reference ranges for any test are specific to that test and laboratory methodology. They are also often age and sex specific. It is not appropriate to include reference range data within the test pages, as they can easily be taken out of context of the circumstances of the test and cannot reflect the complexity involved with the aforementioned factors. Reference ranges will be displayed with the patient results taking these factors into account. These will be available, whether the result is sent via paper, through ward enquiries or via the electronic links to General Practice.
Tests
Turnaround times The laboratory continually monitors its turnaround times to ensure that it complies with its responsibilities within the patient pathway. The laboratory measures its turnaround times as the time from which the sample is booked into the laboratory computer system (which is largely equivalent to the time of receipt), until the point at which the result is authorised (at this point the result is available through direct enquiry and is available for transmission via GP links). These times are routinely published on the trust website. To this end please refer to this information to find the current typical turnaround for individual tests. Referred Tests In addition to the tests listed within this section, the laboratory provides a range of specialist testing which is undertaken at reference centres. Please contact the laboratory for details of the tests offered and information regarding sample requirements.
Author Title Document No.
Peter J Taylor Notes on Test Sets Section
Page 1 of 1 30/11/2007
Directorate of Pathology Estimated Glomerular Filtration Rate (eGFR) Press <TAB> to update values
Calculator corrected for DBH Creatinine Values
DBH Creatinine
100
Patient Age (years)
50
eGFR (Male)
80
eGFR (Female)
59 Multiply eGFR by 1.21 for African-Caribbean patients
Interpretative comments for eGFR values less than 90 mL/min/1.73m2 in accordance with the Department of Health and the UK CKD guidelines. eGFR (mL/min/1.73m2) 60 – 89
Stages of Chronic Kidney Disease (CKD)
30 – 59
eGFR result does not indicate CKD unless there is existing laboratory/clinical evidence of disease Stage 3 CKD – Moderate renal impairment
15 – 29
Stage 4 CKD – Severe renal impairment
< 15
Stage 5 CKD – Very severe or end stage renal failure
These comments are only applicable in patients with stable renal function. Please refer to the Renal Association web site www.Renal.org/eGFR/eguide.html for further information. IMPORTANT CAUTIONS ABOUT eGFR:
Tests
1) eGFR is only an estimate and is not validated for use in: •
Children
•
Acute Renal Failure
•
Pregnancy
•
Oedematous states
•
Malnourished patients
•
Amputees
•
Muscle wasting disease states
2) Creatinine levels must be stable. eGFR calculations assume that the level of creatinine in the blood is stable over days or longer. They are not valid if creatinine levels are changing. 3) Some ethnic minorities may not fit the MDRD equation well. The eGFR result from the laboratory is not corrected for race. For African-Caribbean patients multiply the laboratory eGFR result by 1.21
Author Title Document No.
Peter J Taylor eGFR Calculator PD-UserHbk-06
Page 1 of 1 02/05/2008
Acetyl Choline - Red Cell (ACECHOL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Typically used in monitoring occupational exposure to pesticides.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Acetyl Choline - Red Cell
Activated Partial Thromboplastin time (ACTIVATED P.T.T.) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate Must be filled to the blue line on the side of the tube Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test APTT
Name Activated Partial Thromboplastin Time
Units Seconds
APTT Ratio
A.P.T.T. Ratio
none
Tests
For patient specific reference ranges please refer to printed report or IT systems
Activated Partial Thromboplastin time
Adrenocorticotropic hormone (ACTH) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Test useful in determining the aetiology of proven Cushings syndrome.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Pre-Chilled Tube on Ice - 10 to 15 minutes
Long Term Stability
Not possible
Special Requirements:
Prearrange with laboratory. Cool sample tube to 4째C before drawing blood. Immediately send to laboratory on ice
Tests Test ACTH
Name Adreno Corticotrophin
On Ice
Units ng/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Adrenocorticotropic hormone
Alkaline Phosphatase Isoenzymes (ALPISO) Department:
Clinical Biochemsitry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Used to establish the likely source of isolated elevations in alkaline phosphatase results. Test can identify liver, bone, intestinal and placental isoenzymes. Total ALP should be significantly raised for this test.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Alkaline Phosphatase Isoenzymes
Alpha Foeto Protein (TAFP) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
For use as a marker in monitoring clinically proven cases of liver, ovarian or testicular tumours. Tumour markers are not sufficiently sensitive or specific to use for screening.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test AFP
Name AFP (Tumour marker)
Units KIU/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Alpha Foeto Protein
Alpha-1-Antitrypsin (A1-AT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Any results lower than 1.2 g/L are sent away for Phenotyping. CRP also measured to assess possible acute phase response.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test A1 Anti-trypsin
Name Alpha-1-Antitrypsin
Units g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Alpha-1-Antitrypsin
Amino Acid - Serum (P.AMINO ACID) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Heparin
Request Form:
SST
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Patient should be fasting if possible. Assayed at Sheffield Childrens Hospital
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability
Tests
Special Requirements:
Please state drug history on request
Tests Test Alanine
Name Alanine
Units umol/L
Aminobutyrate
Aminobutyrate
umol/L
Arginine
Arginine
umol/L
Asparagine
Asparagine
umol/L
Aspartate
Aspartate
umol/L
Citrulline
Citrulline
umol/L
Cysteine
Cystine
umol/L
Glutamate
Glutamate
umol/L
Glutamine
Glutamine
umol/L
Glycine
Glycine
umol/L
Histidine
Histidine
umol/L
Isoleucine
Isoleucine
umol/L
Leucine
Leucine
umol/L
Lysine
Lysine
umol/L
Methionine
Methionine
umol/L
Ornithine
Ornithine
umol/L
Phenylalanine
Phenylala.
umol/L
Proline
Proline
umol/L
Serine
Serine
umol/L
Taurine
Taurine
umol/L
Threonine
Threonine
umol/L
Tryptophan
Tryptophan
umol/L
Tyrosine
Tyrosine
umol/L
Valine
Valine
umol/L For patient specific reference ranges please refer to printed report or IT systems Amino Acid - Serum
Amino Acid - Urine (U.AMINO.ACID) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal Requires 25 ml urine. If this is not available from a single voiding collect and free
Tests
Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments:
Single voidings can be mixed and stored FROZEN until 25ml is collected. Qualitative analysis TLC performed initially on site. Referred for quantitation if necessary
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Please state drug history on request
Do not use air transport tube
Tests Test U.Alanine
Name Urine Alanine
Units umol/mmol Creat.
U.Aminobutyrate
Urine Aminobutyrate
umol/mmol Creat.
U.Arginine
Urine Arginine
umol/mmol Creat.
U.Aspartate
Urine Aspartate
umol/mmol Creat.
U.Citruline
Urine Citruline
umol/mmol Creat.
U.Cystine
Urine Cystine
umol/mmol Creat.
U.Glutamate
Urine Glutamate
umol/mmol Creat.
U.Glutamine
Urine Glutamine
umol/mmol Creat.
U.Glycine
Urine Glycine
umol/mmol Creat.
U.Histidine
Urine Histidine
umol/mmol Creat.
U.Homocystine
Urine Homocystine
umol/mmol Creat.
U.Isoleucine
Urine Isoleucine
umol/mmol Creat.
U.Leucine
Urine Leucine
umol/mmol Creat.
U.Lysine
Urine Lysine
umol/mmol Creat.
U.Methionine
Urine Methionine
umol/mmol Creat.
U.Ornithine
Urine Ornithine
umol/mmol Creat.
U.Phenylalanine
Urine Phenylalanine
umol/mmol Creat.
U.Proline
Urine Proline
umol/mmol Creat.
U.Serine
Urine Serine
umol/mmol Creat.
U.Taurine
Urine Taurine
umol/mmol Creat.
U.Threonine
Urine Threonine
umol/mmol Creat.
U.Tyrosine
Urine Tyrosine
umol/mmol Creat.
U.Valine
Urine Valine
umol/mmol Creat.
For patient specific reference ranges please refer to printed report or IT systems
Amino Acid - Urine
Amino Acid TLC (AATLC) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Please state drug history on request
Tests Test TLC Urine AA
Do not use air transport tube
Name TLC AA Screen
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Amino Acid TLC
Aminophylline (THEOPHYLLINE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Timing of sample relative to dose is not important for interpretation but should be maintained as constant as possible within a series of measurements.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Please state drug history on request form Please state TIME of sample on request form
Tests Test Theoph
Name Theophylline
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Aminophylline
Ammonia (AMMONIA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Heparin Container must be fully filled Request Form:
Pathology Combined
Specimen:
Plasma
Availabilty:
Routine hours & On Call
Investigation Comments:
Used in the investigation of acutely sick children for inherited metabolic disorder.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test Ammonia
Name Blood Ammonia
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Ammonia
Amylase - Serum (AMYLASE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
This method is sensitive to Salivary amylase as well as Pancreatic. Elevated results can also occurr due to the presence of Macro Amylase (See urinary Amylase).
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Amylase
Name Amylase
Units U/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Amylase - Serum
Amylase - Urine (UAMY) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments:
Typically used to investigate a mildly elevated amylase result in the absence of clinical signs of pancreatitis or salivary gland pathology. Elevated urinary amylase confirms the serum level is due to the low molecular weight enzyme rather than an antibody-enzyme complex which is not filtered by the kidneys.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Do not use air transport tube
Special Requirements:
Tests Test ACC RATIO
Name ACC Ratio
Units %
P.AMY
ProteinAmylase
U/L
P.CREATININE
ProteinCreatinine
umol/L
U.Amylase
Urine Amylase
U/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Amylase - Urine
Angiotensin Converting Enzyme (ACE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Measurement of serum activity is a useful confirmatory test of sarcoid granulomas if values are elevated, and can be used to monitor the effectiveness of corticosteroid treatments. ACE activity can also be raised in some patients with TB, Gaucher's disease and hyperthyroidism.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test ACE
Name Angiotensin Conv. Enz.
Units IU/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Angiotensin Converting Enzyme
Anti Cardiolipin Antibody (ACA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Anti-phospholipid syndrome & SLE
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test IgM ACL
Name IgM-Anticardiolipin
Units MPLU/ml
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anti Cardiolipin Antibody
Anti Factor 10a Activity - Functional (ANTI XA) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test Anti XA
Name Anti Xa
Units U/ml
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anti Factor 10a Activity - Functional
Anti Glomerular Basement Membrane Antibodies (GBM) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
These antibodies are detected in the majoirty of patients with Goodpasture's syndrome.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test GBM
Name Glomerular Basement Memebrane
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anti Glomerular Basement Membrane Antibodies
Anti Neutophil Cytoplasmic Antibodies (ANCA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Useful in the investigation of Wegeners, microscopic polyangitis, crescentic glomerulonephritis.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Anti-MPO
Name Anti-Myeloperoxidase:
Units
Anti-PR3
Anti-Proteinase 3:
AU/ml
AU/ml
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anti Neutophil Cytoplasmic Antibodies
Anti Nuclear Antibodies (ANA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Diverse group of autoantibodies found in patients with systemic rheumatic diseases.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test ANF
Name Anti-Nuclear Factor
dsDNA
Anti-dsDNA
Pattern
Staining pattern:
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anti Nuclear Antibodies
Anti Phospholipid Antibodies (APA) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate
EDTA
Citrate x 2, EDTA, SST Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test B-Anti Gp1
Name b-Anti Glycoprotein 1
Units units
IgG
IgG
units
IgM
Igm
units
Lupus Screen
Lupus Screen Ratio
none
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anti Phospholipid Antibodies
Anti Streptolysin O (ASO) titre (ASO) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Significant titres: adult >400 IU/ml child >200 IU/ml.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anti Streptolysin O (ASO) titre
Anticoagulation Dosage (ANTI COAGULATION) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate Must be filled to the blue line on the side of the tube Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Dosage by arrangement - contact your lab
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test DOSE
Name Next Dose
Units mg
INR-PT
INR
Unit
NEXT VISIT
Next Appointment
Tests
For patient specific reference ranges please refer to printed report or IT systems
Anticoagulation Dosage
Ascitic Fluid (ASC FL) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Paired Blood Culture
Request Form:
EDTA
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Ascites
Availabilty:
Routinely
Investigation Comments:
For Ascitic fluid investigations for M, C & S: Please inoculate paired blood culture bottles and an EDTA bottle with Ascites for culture and white blood cell count respectively.
Storage Requirements:
Send to the Microbiology immediately after collection.
Short Term Stability
37°C As soon as possible - Overnight
Long Term Stability
Not possible
Special Requirements:
Wash hands and thoroughly disinfect site of collection. Add up to 10mls to each blood culture bottle.
Do not use air transport tube
Tests Test AAFB
Name AAFB Stain (when required)
Units N/A
AAFB CULT
AAFB CAMLiC (on request)
N/A
CULT
Automated Blood Culture (routine)
N/A
dWCC
Differential White Blood Cell Count
/µL
WCC
White Blood Cell Count (routine)
/µL
Tests
For patient specific reference ranges please refer to printed report or IT systems
Ascitic Fluid
Automated White Cell Differential (AUTO DIFF WBC) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
This is an automated WBC differential count produced by an automated analyser
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Baso
Name Basophils
Units x 10^9/L
Eo
Eosinophils
x 10^9/L
Lym
Lymphocytes
x 10^9/L
Mon
Monocytes
x 10^9/L
Neut
Neutrophils
x 10^9/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Automated W hite Cell Differential
Avian Precipitins (AVP) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Useful in the investigation of Bird / Pigeon Fanciers Lung, Extrinsic Allergic Alveolitis
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Budgie Serum
Name Budgie Serum precipitins
Budgie.Faec
Budgie Faecal Extract
Pigeon Serum
Pigeon Serum precipitins
Pigeon.Faec
Pigeon Faecal Extract
Poult.Serum
Poultry Serum precipitins
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Avian Precipitins
Beta-2 -Microglobulin (B2MICROGLO) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Prognostic indicator in multiple myeloma
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Albumin
Name Albumin
Units g/L
Part of LFT and Bone profiles
B2Microglob
B2 Microglobulin
mg/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Beta-2 -Microglobulin
Bicarbonate (BIC) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Bicarbonate is not stable once the sample tube is opened. This test cannot be added to a sample which has already been analysed. Specific request only as part of U&E profile
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Bicarbonate
Name Bicarbonate
Units mmol/L
Specific request only as part of U&E profile
Ions Diff
Ions Difference
mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Bicarbonate
Bile Acids (BILE ACIDS) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Only useful for investigation of icterus and itching in pregnancy
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Bile Acids
Name Bile Acids
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Bile Acids
Blood Cultures (BC) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Blood Culture Bottles Blood culture bottles (Adult or Paediatric) Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood, Arterial Blood or Blood via IV line
Availabilty:
Routinely (when required)
Investigation Comments:
Incubate for 5 days. All significant positive results phoned.
Storage Requirements:
Transport to laboratory without delay, place in incubator in Pathology outside normal laboratory hours. DO NOT fridge Blood cultures.
Short Term Stability
37째C As soon as possible - Overnight
Long Term Stability
37째C
Special Requirements:
Wash hands and thoroughly disinfect skin at site of venepuncture before collection. Add up to 10mls to each bottle (5ml to single paediatric bottle). For patients with suspected endocarditis collect 3 sets from separate venepunctures at different times.
Tests Test BC
Do not use air transport tube
Name Automated Blood culture
Units N/A
Tests
For patient specific reference ranges please refer to printed report or IT systems
Blood Cultures
Blood Gas (BGAS) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Anaerobic Heparin Blood Gas Syringe / Capillary Request Form:
Pathology Combined
Specimen:
Arterial Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Please ensure handwritten label is used Contact laboratory staff before taking. Send sample packed on ice.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Transport on Ice - Up to 10 minutes
Long Term Stability
Not possible
Do not use air transport tube
Tests
Special Requirements:
Tests Test [H ION]
Name Hydrogen Ion Conc
Units nmol/L
Base Def
Base Deficit
mmol/L
Base XS
Base Excess
mmol/L
Inspired O2
Inspired Oxygen
O2 Sat
O2 Saturation
%
pCO2
pCO2
kpa
pH
pH
pH units
pO2
pO2
kpa
Spec.Type
Specimen Type
Stat Cl
Stat.Cl
Stat Hct
Stat.Hct
Stat iCa
Stat Ionised Ca
mmol/L
Stat K
Stat.K
mmol/L
Stat Na
Stat Na
mmol/L
Std Bic
Std.Bicarb
mmol/L
mmol/L
For patient specific reference ranges please refer to printed report or IT systems
Blood Gas
Blood Volume Studies (BVS) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Contact consultant Haematologist
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Blood Volume Studies
Bone Marrow Biopsy (MARROW) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Histology Pot
Request Form:
Pathology Combined
Specimen:
Marrow
Availabilty:
By arrangement with the Consultant Haematologist
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Bone Marrow Biopsy
Bone Profile (BONE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
A fasting sample is preferable when investigating disorders of calcium metabolism
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Albumin
Name Albumin
Units g/L
Part of LFT and Bone profiles
Alk.Phos
Alk.Phos
U/L
Part of LFT and Bone profiles
Ca(Alb Corr)
Calcium (Albumin Corrected)
mmol/L
Calcium
Calcium
mmol/L
Globulin
Globulin
g/L
Phosphate
Phosphate
mmol/L
T.Protein
Total Protein
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Bone Profile
Bronchial Washings / Bronchial Alveolar Lavage (BAL) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Bronchial washing or Bronchial Alveolar Lavage
Availabilty:
Routinely
Investigation Comments:
Optimally collected before antimicrobial treatment started. Include relevant clinical details
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours, samples should be placed in the pathology reception fridge.
Short Term Stability
24hrs
Long Term Stability
Ambient Temperature
Special Requirements:
Danger of Infection stickers must be used when Mycobacterial infection is suspected.
Tests Test AAFB MICRO
Name AAFB Microscopy (routinely)
AAFB CULT
Culture (CAMLiC) for Mycobacteria
AAFB SENS
AAFB Sensitivity Testing
BAL/BW CULT
Bacterial culture (routinely)
Units
BAL/BW FUNGAL CULT Fungal culture (routinely) BAL/BW SENS
Routine antimicrobial sensitivity testing
GRAM
Gram film (routinely)
PCP IFT
Pneumocystis carinii IFT (on request only)
Tests
For patient specific reference ranges please refer to printed report or IT systems
Bronchial W ashings / Bronchial Alveolar Lavage
C1 Esterase (C1EST) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Useful in the investigation of Type II HAE & acquired angioedema. Complement C3 & C4 also requested. Functional levels measured on patients with low C1 and C4
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test C1 Est.Func
Name C1 Esterase Functional
Units U/L
C1 Esterase
C1 Esterase Level
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
C1 Esterase
C3/C4 (COMP) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Fluid
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test Comp.C3c
Name Complement C3c
Units g/L
Comp.C4
Complement C4
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
C3/C4
CA125 (CA125) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
For use as a marker in monitoring clinically proven cases of ovarian tumours. Tumour markers are not sufficiently sensitive or specific to use for screening.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test CA125
Name CA125
Units kU/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
CA125
Caeruloplasmin (CPN) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Copper binding serum protein. Used in cojunction with serum copper levels, to diagnose Wilson's disease.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test C.Plasmin
Name Caeruloplasmin
Units g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Caeruloplasmin
Caffeine (CAFFEINE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Take blood sample just before dose (trough levels) Sample taken immediately before a dose
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Caffeine
Name Caffeine
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Caffeine
Calcium - Urine (UCA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Universal
24hr Urine container with Acid Preservative Request Form:
Pathology Combined
Specimen:
24hour Urine or Random Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient - 12 hours
Long Term Stability
Specimens over 12 hours may be rejected
Special Requirements:
Tests Test U.Ca.Conc
Name Urine Calcium Conc.
Units mmol/L
U.Ca.Ex
Urine Calcium Excretion
mmol/24hr
U.Cr Exc
Urine Creat.Excretion
mmol/24hr
U.Creat.Conc
Urine Creat.Conc.
mmol/L
U.Phos.Conc
Urine Phosphate Conc.
mmol/L
U.Phos.Ex
Urine Phosphate Excretion
mmol/24hr
U.Volume
24 Hr Urine Volume.
Litres
Tests
For patient specific reference ranges please refer to printed report or IT systems
Calcium - Urine
Carbamezapine (Tegritol) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Sample taken immediately before a dose. In cases where toxicity is suspected 3-4 hours post dose.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Carbamaz
Name Carbamazepine
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Carbamezapine
Carboxy-Haemoglobin (COHB) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
EDTA Full EDTA Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Measures % of carbon monoxide bound to haemoglobin. Unlikely to be significantly increased if oxygen saturation >85%
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Do not leave air space in bottle. Protect from light.
Tests Test COHB
Name Carboxy Hb.
Units %
FUNC.OSAT
Func.O2 Saturation
%
METHB
Met. Hb.
%
Tests
For patient specific reference ranges please refer to printed report or IT systems
Carboxy-Haemoglobin
Carcinoembryonic Antigen (CEA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
For use as a marker in monitoring clinically proven cases of colorectal carcinoma. Tumour markers are not sufficiently sensitive or specific to use for screening.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test CEA
Name Carcinoembryonic Ag.
Units ng/ml
Tests
For patient specific reference ranges please refer to printed report or IT systems
Carcinoembryonic Antigen
Catecholamines (CATS) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Universal
24hr Urine container with Acid Preservative Request Form:
Pathology Combined
Specimen:
24hour Urine
Availabilty:
Routine hours only
Investigation Comments:
Test used in the diagnosis of phaeochromocytoma Sample will be rejected if pH of 24hr urine >3.5
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
State all current drugs on request form
Tests Test Adrenaline
Name Adrenaline
Units umol/24hr
Dopamine
Dopamine
umol/24hr
HIAA
HIAA
umol/24hr
HMMA
HMMA
umol/24hr
HVA
HVA
umol/24hr
Noradrenaline
Noradrenaline
umol/24hr
U.Cr Excretion
Urine Creat.Excretion
mmol/24hr
Volume.
24 hr.Urine Volume
Litres
Tests
For patient specific reference ranges please refer to printed report or IT systems
Catecholamines
Catecholamines - Paediatric (PCATS) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal Obtain special container from lab as it needs to be acidified Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test PADR.
Name Paed Adren
Units umol/10mmolCr
PCREAT.
Urine Creat.Excretion
mmol/24hr
PDOPA.
Paed Dopam
umol/10mmolCr
PHMMA.
Paed HMMA
umol/10mmolCr
PHVA.
Paed HVA
umol/10mmolCr
PNORAD.
Paed Norad
umol/10mmolCr
PVOL
24 hr.Urine Volume
Litres
Tests
For patient specific reference ranges please refer to printed report or IT systems
Catecholamines - Paediatric
Cerebro Spinal Fluid (CSF) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Cerebro-Spinal Fluid
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability Special Requirements:
Tests Test Glucose
Name CSF Glucose
Pandys
Pandys Test
Protein
CSF Protein
Visual
Appearance
Units mmol/L g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cerebro Spinal Fluid
Cerebro Spinal Fluid - Cytology (CSF) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile Universal Request Form:
Histology WPR2580
Specimen:
Cerebro-Spinal Fluid
Availabilty:
Monday to Friday - samples to arrive before 4pm
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cerebro Spinal Fluid - Cytology
Cerebro Spinal Fluid - Microbiology (CSFM) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Cerebro-Spinal Fluid
Availabilty:
24 hours daily
Investigation Comments:
Include relevant clinical details
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be placed in the pathology reception fridge and the on-call microbiologist contacted through switchboard.
Short Term Stability Long Term Stability Special Requirements:
Do not use air transport tube
Always contact the laboratory when sending specimens. Ideally collect the CSF sample in 3 consecutive universal containers. Labelled 1 to 3 accordingly. Ensure bottles 1 & 3 are sent to Microbiology
Tests Test AAFB
Name AAFB Stain (when required)
Culture
Bacterial culture (routine)
Gram
Gram film (perfomed when required)
India ink
Cryptococccal stain (when required)
Red blood cells
RBC Count (routine)
/ÂľL
White blood cells
Differential WBC count (routine)
%
White blood cells
WBC count (routine)
/ÂľL
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cerebro Spinal Fluid - Microbiology
Cervical Cytology (Gynaecological Cytology) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Surepath LBC Vial
Request Form:
Specimen:
HMR101 Cytology Request Form
Liquid based cervical cytology
Availabilty: Investigation Comments:
Brush head must be present in vial. If two sample devices are used for a single patient, both sample device heads may be placed in a single vial.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Sample takers must be trained in liquid based cytology prior to taking samples and have a personal identification number. The PIN number must be indicated on the request form. Samples received without this information will not be processed. Sample vials must be hand labelled. Addressograph labels cannot be used. Vials received with addressograph labels will not be processed.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cervical Cytology
Cervical swab culture (GC) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Swab
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Charcoal Transport Swab
Availabilty:
Routinely
Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability
24 hours
Long Term Stability Special Requirements:
Tests Test GC culture
Name Routine culture for GC
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cervical swab culture
Chlamydia Detection (CSDA) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
Chlamydia Swab
Request Form:
Universal
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Eye, Cervical, Urethral or first void urine
Availabilty: Investigation Comments:
Send in either pink chlamydia swab or 15ml of first void urine for genital infections. Send Blue swab for occular infections Swabs available from Pathology reception.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Chlamydia Detection
Cholesterol (CHOL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Ideally patient should be fasted overnight Part of Lipid profile. Clearly mark form as Fasting or Non-Fasting
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Cholesterol
Name Cholesterol
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cholesterol
Coagulation Screen (CLOTTING TESTS) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate Must be filled to the blue line on the side of the tube Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test APTT
Name Activated partial thromboplastin time
Units Seconds
APTTR
Aptt Ratio
none
BT
Bleeding Time
Seconds
D-DIMER
D-Dimer
mgm/l
INR
I.N.R.
units
PT
Prothrombin Time
Seconds
RT
Reptilase Time
Seconds
TT
Thrombin Time
Seconds
Tests
For patient specific reference ranges please refer to printed report or IT systems
Coagulation Screen
Complement C2 (C2.) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Classical pathway activation, usually immune complex disease.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test C2ASENT
Name Sent:
Complmnt C2
Complement C2:
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Complement C2
Complement Levels C5 - C9 (CO59) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Deficiency - discuss with consultant immunologist
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Complmnt C5
Name Complement C5:
Complmnt C6
Complement C6:
Complmnt C7
Complement C7
Complmnt C8
Complement C8:
Complmnt C9
Complement C9:
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Complement Levels C5 - C9
Continuous Ambulatory Peritoneal Dialysis Fluid (CAPD) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
CAPD Fluid
Availabilty:
24 hours
Investigation Comments:
Include relevant clinical details
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be placed in the pathology reception fridge and the on-call microbiologist contacted through switchboard.
Short Term Stability Long Term Stability
Not possible
Special Requirements:
Always contact the laboratory when sending specimens. Ideally collect the CAPD sample in 2 sterile universal containers.
Tests Test AAFB
Name AAFB Stain (when required)
Culture
Bacterial culture (routine)
Gram
Gram Film
White blood cells
White blood cell count
Do not use air transport tube
Units
/ÂľL
Tests
For patient specific reference ranges please refer to printed report or IT systems
Continuous Ambulatory Peritoneal Dialysis Fluid
Cortisol - Serum (CORTISOL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
For ? Addison's Disease, a Synacthen test is more appropriate. Contact laboratory for protocol
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Blood sample should be collected before 10.00am
Tests Test Cortisol
Name Cortisol
Units nmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cortisol - Serum
Cortisol - Urine (UCORT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Request Form:
Pathology Combined
Specimen:
24hour Urine
Availabilty:
Routine hours only
Investigation Comments:
Useful in the diagnosis of Cushingâ&#x20AC;&#x2122;s syndrome
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10°C
Special Requirements:
Tests Test U.Cortisol
Name Urine Free Cortisol
Units nmol/24Hr.
U.Volume
24 Hr Urine Volume.
Litres
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cortisol - Urine
C-Reactive Protein (CRP) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Acute phase protein, particularly raised in bacterial infection
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test CRP..
Name C-Reactive Protein
Units mg/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
C-Reactive Protein
Creatine Kinase (CK) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Present in heart muscle, skeletal muscle and brain. Raises 4 - 24hours after MI
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test CK
Name Creatine Kinase
Units U/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Creatine Kinase
Creatinine (UCR) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Request Form:
Pathology Combined
Specimen:
24hour Urine
Availabilty:
Routine hours only
Investigation Comments:
Part of U&E profile. Not a good indicator of early renal disease.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test U.Creat.Conc
Name Urine Creat.Conc.
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Creatinine
Creatinine Clearance (CRCL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Request Form:
SST
Pathology Combined
Specimen:
24hour Urine & Venous blood
Availabilty:
Routine hours only
Investigation Comments:
Venous blood sample must be taken during the collection period for the 24 Hour urine.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient - 12 hours
Long Term Stability
Specimens over 12 hours may be rejected
Special Requirements:
Tests Test Cr.Clearance
Name Cr.Clearance
Units ml/Min.
P.Creat.Conc
ProteinCreat
umol/L
U.Creat.Conc
Urine Creat.Conc.
mmol/L
U.Volume
Urine Volume
L/24 Hr
Tests
For patient specific reference ranges please refer to printed report or IT systems
Creatinine Clearance
Cryoglobulins (CRY) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Plain
Plain
2 Plain tubes required Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Samples must be kept at 37째C until processed by the laboratory.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
37째C As soon as possible - Overnight
Long Term Stability
37째C
Special Requirements:
Must contact the laboratory before collecting blood
Tests Test Cryoglob
Name Cryoglobulin:
Units
IgA 37C
IgA:
g/L
IgA 4C
IgA:
g/L
IgG 37C
IgG:
g/L
IgG 4C
IgG:
g/L
IgM 37C
IgM:
g/L
IgM 4C
IgM:
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cryoglobulins
CSF IgG (CIGS) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
SST
Pathology Combined
Specimen:
Cerebro-Spinal Fluid & Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
CSF and Blood must be sent together.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test CALB
Name CSF Albumin:
Units mg/L
CIGG
CSF IgG:
mg/L
GARAT
CSF IgG/Alb Ratio:
MSRAT
CSF:Serum IgG/Alb Ratio:
OLIG
Oligoclonal Bands:
SALB
Serum Albumin:
g/L
SIGG
Serum IgG:
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
CSF IgG
Cytomegalovirus (CMV) Serology (CMV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Include clinical details
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Cytomegalovirus (CMV) Serology
D-Dimer (Venous Thromboembolism Screen) (VTE D-DIMER) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Please phone and send directly to the DRI coag lab
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test VTE DDIMER
"Wells Score" or equivalent must be quoted on all requests Name VTE D Dimer
Units ug FEU/l
Tests
For patient specific reference ranges please refer to printed report or IT systems
D-Dimer (Venous Thromboembolism Screen)
Digoxin (DIGOXIN) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
For monitoring response to the dose, the sample must be taken 6 to 8 hours post dose. Include date & time of sample draw & of last dose on the request form.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Digoxin
Name Digoxin
Units nmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Digoxin
Dipstick (USCR) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test U.BIL
Name Urine Bilirubin
U.BLOOD
Urine Blood
U.GLUC
Urine Glucose
U.KET
Urine Ketone
U.NITRITE
Urine Nitrite
U.PH
Urine pH
U.PRO
Urine Protein
U.REDUCING SUBST
Urine Reducing Sub.
U.SULPHITE
Urine Sulphite
U.UBG
Urine Urobilinogen
Units
pH Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Dipstick
Direct immunofluorescence testing (DIF) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile universal with specimen in saline soaked gauze Request Form:
Histology WPR2580
Specimen:
Skin biopsy (half an ellipse of skin or a punch biopsy) Other specimens may be processed with prior arrangement
Availabilty:
Mon to Fri - sample to arrive at DRI before 4.30pm
Investigation Comments:
Please telephone the laboratory at DRI or BDGH to inform of imminent sample. High risk samples will be evaluated on a case by case basis and only processed for DIF with the agreement of the reporting pathologist.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Only one request form is required, listing specimens and relevant investigations clearly. All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Direct immunofluorescence testing
Drugs of Abuse Screen (ABUSED DRU) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal Minimum volume 20ml Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments:
Semi-quantitative screening tests for identification of the different drug classes. Positive results are confirmed using thin-layer chromatography (off site)
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Amphetamines
Name Amphetamines
Amphetamines Class
Amphetamine Class
Benzodiazepines
Benzodiazepines
Cannabinoids
Cannabinoids
CocaineMetab
Cocaine metabolites
Methadone
Methadone
Opiates
Opiates
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Drugs of Abuse Screen
Electrolyes - Serum (ELU) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
Available
Special Requirements:
Tests Test Creatinine
Name Creatinine
Units umol/L
Potassium
Potassium
mmol/L
Sodium
Sodium
mmol/L
Urea
Urea
mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Electrolyes - Serum
Electrolytes - 24hr Urine (UELU) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Request Form:
Pathology Combined
Specimen:
24hour Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Do not use air transport tube
Special Requirements:
Tests Test U.Cl.Conc
Name Urine Chloride Conc.
Units mmol/L
U.Cl.Ex
Urine Chloride Excretion
mmol/24hr
U.Cr Exc
Urine Creat.Excretion
mmol/24hr
U.Creat.Conc
Urine Creat.Conc.
mmol/L
U.K.Conc
Urine Potassium Conc.
mmol/L
U.K.Ex
Urine Potassium Excretion
mmol/24hr
U.Na.Conc
Urine Sodium Conc.
mmol/L
U.Na.Ex
Urine Sodium Excretion
mmol/24hr
U.Urea.Conc
Urine Urea Conc.
mmol/L
U.Urea.Ex
Urine Urea Excretion
mmol/24hr
U.Volume
24 Hr Urine Volume.
Litres
Tests
For patient specific reference ranges please refer to printed report or IT systems
Electrolytes - 24hr Urine
Electrolytes - Random Urine (RUELU) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal Mid Stream Urine Container Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Do not use air transport tube
Special Requirements:
Tests Test U.Cl.Conc
Name Urine Chloride Conc.
Units mmol/L
U.Creat.Conc
Urine Creat. Conc
mmol/L
U.K.Conc
Urine Potassium Conc.
mmol/L
U.Na.Conc
Urine Sodium Conc.
mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Electrolytes - Random Urine
Epstein Barr Virus (EBV) Serology (EBV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Epstein Barr Virus (EBV) Serology
Erythrocyte Sedimentation Rate - Automated (ESR) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test
Name Comment
Units
ESR
ESR
mm
ESRWEST
ESR West
mm
PIPETTE NO
Pipette No
SEDTIME
Sed.Time
Mins
TEMP
Temp
Deg C
Tests
For patient specific reference ranges please refer to printed report or IT systems
Erythrocyte Sedimentation Rate - Automated
Erythrocyte Sedimentation Rate - Manual (BSR) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Black Citrate Black citrate container required Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test ESR
Name ESR
Units mm
Tests
For patient specific reference ranges please refer to printed report or IT systems
Erythrocyte Sedimentation Rate - Manual
Ethanol (ETHANOL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Fluoride Oxalate
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Always allow bottle to completely fill
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Tests Test Ethanol
Name Ethanol
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Ethanol
Extractable Nuclear Antigens (ENA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Immunofluorescence screening test. Useful in the investigation of CTD,(SLE, SSCLE, Sjogrens, MCTD, overlap syndromes), polymyositis, scleroderma.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Anti-La
Name Anti-SSB
Anti-RNP
Anti-RNP
Anti-Ro
Anti-SSA
Anti-Scl70
Anti-Scl70
Anti-Sm
Anti-Sm
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Extractable Nuclear Antigens
Faecal Microscopy (FAECES) Department:
Microbiology
Contact:
01302 366666 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Faeces
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Faeces
Availabilty:
On request
Investigation Comments:
Include relevant clinical details
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours, samples should be refrigerated at 4-10 C
Short Term Stability Long Term Stability Special Requirements:
If amoebic dysentry is suspected, please send stool within 2hrs of passage
Tests Test
Name
MICROSCOPY
Microscopy
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Faecal Microscopy
Faecal Occult Blood (FOB) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Faeces Walnut size piece, do not overfill container Request Form:
Pathology Combined
Specimen:
Faeces
Availabilty:
Routine hours only
Investigation Comments:
Investigation suspect blood loss from GI Tract
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test Occult Blood
Name Faecal Occult Blood
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Faecal Occult Blood
Faeces Culture (FAECES) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Faeces
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Faeces
Availabilty:
Routinely
Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be placed in the pathology reception fridge.
Short Term Stability Long Term Stability Special Requirements:
Please provide information regarding recent foreign travel and antibiotic use. Clostridium difficile toxin test performed on in-patient samples, patients over 65yrs or if history of antibiotic-associated diarrhoea. Rotavirus tested on samples from children <5 years. Repeat samples for microbiological clearance not usually required - Microbiologists will advise if necessary.
Tests Test
Name
C. Difficile
C difficile toxin when required
Cryptosporidium
Routine microscopy for cryptosporidium
Culture
Routine Culture
OCP
Routine wet film for OCP
Rotavirus
Rotavirus EIA when required
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Faeces Culture
Ferritin (FERRITIN) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test FERRIT
Name Ferritin
Units ug/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Ferritin
Fibrinogen Level (FIBRINOGEN) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Will also be requested by lab staff as appropriate
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test FIB
Name Fibrinogen
Units g/l
Tests
For patient specific reference ranges please refer to printed report or IT systems
Fibrinogen Level
Fine Needle Aspiration Cytology (FNA) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Universal containing cytospin collection fluid (Green Fluid) Request Form:
Histology WPR2580
Specimen:
Aspirated tissue sample
Availabilty:
Mon to Fri - sample to arrive at DRI before 4.00pm
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - Do not refrigerate
Long Term Stability
Ambient Temperature
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Only one request form is required, listing specimens and relevant investigations clearly. All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Fine Needle Aspiration Cytology
Fluid (FLUID) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Fluid
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test F.Albumin
Name F. Albumin
Units g/L
F.Amylase
F.Amylase
U/L
F.Bicarbonate
F. Bicarb
mmol/L
F.Chloride
F. Cl
mmol/L
F.Creatinine
F.Creatinine
umol/l
F.Globulin
F. Globulin
g/L
F.Glucose
F. Glucose
mmol/L
F.Potassium
F.Potassium
mmol/L
F.Protein
F.Tot. Prot
g/L
F.Sodium
F.Sodium
mmol/L
F.Urate
F.Urate
umol/L
F.Urea
F.Urea
mmol/L
Source
Spec. Name
Tests
For patient specific reference ranges please refer to printed report or IT systems
Fluid
Fluids - Cytology (Ascites, Pleural, Peritoneal, Urine) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile universal Request Form:
Histology WPR2580
Specimen:
Fluid
Availabilty:
Mon to Fri - sample to arrive at DRI before 4.00pm
Investigation Comments:
If a larger volume of fluid has been collected please decant a 25 ml sample for cytology investigations. Please do not send a greater volume than 25 ml, or multiple samples of 25 ml unless from separate areas or for separate investigations.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Refrigerate if left overnight
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Only one request form is required, listing specimens clearly. All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Fluids - Cytology
Follicle Stimulating Hormone (FSH) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
assessment of Ovarian failure (menopause), pituitary dysfunction and infertility. Most informative on day 3 of cycle Levels vary through menstrual cycle. Sample blood between days 2-7 of the cycle (follicular phase)
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Levels vary through menstrual cycle. Sample blood between days 2-7 of the cycle (follicular phase)
Tests Test Follitrophin
Name Follitrophin
Units U/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Follicle Stimulating Hormone
Free T3 (FT3) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Free T3 measurement is of no value in the diagnosis of hypothyroidism.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test FT3
Name Free T3
Units pmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Free T3
Full Blood Count (FBC) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Hb
Name Haemoglobin
Hct
Haematocrit
MCH
Mean Corpuscular Haemoglobin
pg
MCHC
Mean Corpuscular Haemoglobin Conc.
g/dL
MCV
Mean Corpuscular Volume
fL
Plts
Platelets
x 10^9/L
RBC
Red Blood Cells
x 10^12/L
RDW
Red Cell Distribution Width
%
WBC
White Blood Cells
x 10^9/L
Units g/dL.
Tests
For patient specific reference ranges please refer to printed report or IT systems
Full Blood Count
Gentamicin Assays (GENTA) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty:
Mon-Fri 0900-2000, Sat 0900-1200, Out of hours - by approvement of Consulta
Investigation Comments:
Please complete "Assay Request Forms" in full, specific labels for assay samples are available. These can be obtained from Pathology Reception. Assays with incomplete dosing and specimen details will be rejected.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Gentamicin
Name Gentamicin
Units mg/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Gentamicin Assays
Gestational Glucose Tolerance Test (GGTT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Fluoride Oxalate
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Refer to Oral Glucose Tolerance Test
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Tests Test Glucose
Name Glucose
Spec.Time
S.TIME
U Protein
Urine Protein
U.Glucose
Urine Glucose
U.Ketones
Urine Ketone
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Gestational Glucose Tolerance Test
Glandular Fever Test (GFT) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
SST
Request Form:
EDTA
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Will also be requested by lab staff as indicated by other results
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test GFT
Name Glandular Fever Test
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Glandular Fever Test
Gliadin Antibodies (GLI) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Part of the Coeliac disease screen Anti gliadin antibodies also present in dermatitis herpetiformis. IgG antigliadin antibodies also found in many 'leaky' bowel disorders
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Endomysial
Name Endomysial Ab:
IgA Gliadin
IgA Anti-Gliadin:
IgG Gliadin
IgG Anti-Gliadin:
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Gliadin Antibodies
Glucose (GLUCOSE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Fluoride Oxalate
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Tests Test Glucose
Name Glucose
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Glucose
Glucose Tolerance Test (OGTT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Fluoride Oxalate
Fluoride Oxalate
2 x fluoride Oxalate containers required Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Protocol used to assess glucose handling at 0 and 2 hours following a glucose load.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Arrange by laboratory. Phone: 3535 (DRI) or 2481 (BDGH)
Tests Test Glucose
Name Glucose
Spec.Time
S.TIME
U Protein
Urine Protein
U.Glucose
Urine Glucose
U.Ketones
Urine Ketone
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Glucose Tolerance Test
Glucose Tolerance Test (2 samples) (2GTT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Fluoride Oxalate
Fluoride Oxalate
2 x fluoride Oxalate containers required Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Protocol used to assess glucose handling at 0 and 2 hours following a glucose load.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Arrange by laboratory. Phone: 3535 (DRI) or 2481 (BDGH)
Tests Test Glucose
Name Glucose
Spec.Time
S.TIME
U Protein
Urine Protein
U.Glucose
Urine Glucose
U.Ketones
Urine Ketone
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Glucose Tolerance Test (2 samples)
Group B Streptococci (GBS) Screen (HVS) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Swab
Request Form:
Universal
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
HVS / Introital swab / Rectal swab / Urine
Availabilty:
Routinely
Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test GBS Screen
Name Group B Streptococci Screen
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Group B Streptococci (GBS) Screen
Haemochromatosis gene (HHG) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Haemochromatosis gene
Haemoglobin A1c (HBA1C) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Results are consistent with the DCCT and UKPDS trials. Some haemoglobin variants may interfere with the analysis Test used to monitor glycaemic control in patients with diabetes mellitus
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Tests Test HbA1c
Name HbA1c
Units %
Tests
For patient specific reference ranges please refer to printed report or IT systems
Haemoglobin A1c
Hb Electrophoresis (HBE) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
EDTA
EDTA x 2 Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test HBA2
Name Haemoglobin A2
HBELEC
Haemoglobin Electrophoresis
HBF
Haemoglobin F
HBS
Sickle Test for Haemoglobin S
HBSTR
Haemoglobin Structure
ZINC PROT
Zinc Protoporphyrin
Units % %
umol/mol(Hb)
Tests
For patient specific reference ranges please refer to printed report or IT systems
Hb Electrophoresis
Helicobacter pylori serology (HPY) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Should not be used as a test of eradication. Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Helicobacter pylori serology
Hepatitis A IgM (HAVM) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Specimen:
Pathology Combined
Venous Blood
Availabilty: Investigation Comments:
Part of acute Hepatitis investigation screen
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Hepatitis A IgM
Hepatitis A Total antibody (HAV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
IgG tested prior to vaccination only in patients >50 years. Post vaccination testing is not required.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Hepatitis A Total antibody
Hepatitis B serology (HBSAG) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Part of acute Hepatitis investigation screen Hepatitis B surface antigen tested as screen in acute or chronic infection. Hepatitis B core antibody and Hepatitis e antigen/antibody tested dependent on results and clinical history
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Hepatitis B serology
Hepatitis C serology (HCV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Part of acute Hepatitis investigation screen Positive 6 weeks after acute infection
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Hepatitis C serology
Herpes simplex virus (HSV) culture (HSV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
Swab Swab in viral transport medium Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Viral Swab
Availabilty: Investigation Comments:
Do not use charcoal swabs. Swabs and transport media available from specimen reception.
Storage Requirements:
Store transport medium in fridge prior to use. Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Herpes simplex virus (HSV) culture
High Vaginal Swab Culture (HVS) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Transport swab
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Charcoal Transport swab
Availabilty:
Routinely
Investigation Comments:
If GBS screen required please state on request form
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test HVS Culture
Name Routine bacterial & fungal culture
HVS microscopy
Routine microscopy for TV & BV
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
High Vaginal Swab Culture
Histology (Routine Histology) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Histology Pot
Request Form:
Histology WPR2580
Specimen:
Tissue biopsy / resection
Availabilty:
Monday to Friday
Investigation Comments:
Not suitable for frozen section or DIF. Refer to relevant sections of handbook
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - Do not refrigerate
Long Term Stability
Ambient Temperature - Do not refrigerate
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Only one request form is required, listing specimens clearly. Ensure left and right samples from the same patient are clearly labelled. All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Histology
Human Immunodeficiency virus (HIV) serology (HIV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Patient consent essential, pre-test counselling may be arranged with GUM. Can be tested urgently if required, following discussion with Microbiologist. Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Human Immunodeficiency virus (HIV) serology
Immunity screen (REF) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Can test for immune response post vaccination e.g. Diphtheria, Hib,Tetanus and Pnumococcal
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Immunity screen
Immunoglobulins (Serum) (IGS.) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Diagnosis and monitoring of primary and secondary immunodeficiencies: monitoring patients receiving replacement therapies, myeloma screen
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Albumin
Name Albumin
Units g/L
Part of LFT and Bone profiles
Glob gap
Glob gap
g/L
Globulin
Globulin
g/L
IGA
Immunoglobulin A
g/L
IGG
Immunoglobulin G
g/L
IGM
Immunoglobulin M
g/L
T.Protein
Total Protein
g/L
Total Ig
Tot Ig
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Immunoglobulins (Serum)
Intra-Operative Frozen Section (Frozen Section) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile universal Request Form:
Histology WPR2580
Specimen:
Tissue Other specimens may be processed with prior arrangement
Availabilty:
Monday to Friday
Investigation Comments:
Prior arrangement is essential for frozen sections. Please telephone the laboratory at least 24 hrs in advance of a planned intra operative frozen section. Telephone the laboratory to warn of the sampleâ&#x20AC;&#x2122;s imminent arrival. All samples should arrive in the laboratory before 4pm. Intra operative frozen sections on high risk patients are actively discouraged and these cases should be discussed with a pathologist prior to booking.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Each frozen section should be accompanied by a separate form.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Intra-Operative Frozen Section
Intrinsic Factor Antibody () Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only - Assayed at DRI weekly
Investigation Comments:
Will also be requested by staff as indicated by other results
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test IFA
Name Intrinsic Factor Antibody
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Intrinsic Factor Antibody
Iron (IRON) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Assayed in cases of suspected overdose only Ferritin is a better indicator of iron storage and in cases of iron overload
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Iron
Name Iron
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Iron
Lactate - CSF (CSFLACTATE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Fluoride Oxalate
Request Form:
Pathology Combined
Specimen:
Cerebro-Spinal Fluid
Availabilty:
Routine hours only - Must pre-arrange with the laboratory
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test CSFLactate
Name CSF Lactate
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Lactate - CSF
Lactate - Serum (LACTATE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Fluoride Oxalate
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Pre-arrange with the laboratory. Transport to laboratory immediately on ice
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Transport on Ice - Up to 10 minutes
Long Term Stability
Not possible
On Ice
Special Requirements:
Tests Test Lactate
Name Lactate
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Lactate - Serum
Lactate dehydrogenase (LDH) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous blood
Availabilty:
Routine hours only
Investigation Comments:
Measured in megaloblastic and pernicious anaemia, leukaemia and lymphomas.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test LDH
Name Lactate Dehydrogenase
Units U/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Lactate dehydrogenase
Lactate dehydrogenase - Fluid (F.LDH) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Fluid
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test F.LDH
Name LDH
Source
Spec. Name
Units U/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Lactate dehydrogenase - Fluid
Legionella Antigen (LEGAG) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
sterile universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Urine
Availabilty: Investigation Comments:
Please state date of onset of symptoms and travel history or exposure history
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Legionella Antigen
Lipid Screen () Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Specimen:
Pathology Combined
Venous Blood
Availabilty: Investigation Comments:
LDL - Cholesterol Calculated value. Calculation invalid if Triglyceride > 4.6 mmol/L or non-fasting blood sample received for testing
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Cholesterol
Name Cholesterol
Units mmol/L
HDL-Chol
HDL-Cholesterol
mmol/L
HDL-Ratio
HDL-Ratio
LDL
LDL
mmolL
Triglyceride
Triglyceride
mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Lipid Screen
Lithium (LI) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Specimen:
Pathology Combined
Venous Blood
Availabilty: Investigation Comments:
Take blood sample 12 hours from the last dose. Note dosage on request form. Request U&E at the same time to monitor Creatinine
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Dosage
Name Dosage
Frequency
Frequency
HPD
Hours Post Dose
hours
Lithium
Lithium
mmol/L
Units mg
Tests
For patient specific reference ranges please refer to printed report or IT systems
Lithium
Liver / Kidney Autoantibody Screen (LKS) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test AMA
Name Anti Mitochondrial Antibodies
ASM
Anti Smooth Muscle Antibodies
GPC
Anti Gastric Parietal Cell Antibodies
LKM
Liver / Kidney Microsome
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Liver / Kidney Autoantibody Screen
Liver Function Tests (LFT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Albumin
Name Albumin
Units g/L
Part of LFT and Bone profiles
Alk.Phos
Alkaline Phosphatase
U/L
Part of LFT and Bone profiles
AST
AST
U/L
GGT
Gamma GT
U/L
Globulin
Globulin
g/L
T.Bilirubin
T.Bilirubin
umol/L
T.Protein
Total Protein
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Liver Function Tests
Low Density Lipids - Cholesterol (LDL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Part of Lipid profile LDL - Cholesterol Calculated value. Calculation invalid if Triglyceride > 4.6 mmol/L or non-fasting blood sample received for testing
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test LDL
Name LDL
Units mmolL
Tests
For patient specific reference ranges please refer to printed report or IT systems
Low Density Lipids - Cholesterol
Lutrophin (LH) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Assesment of ovarian failure (menopause), pituitary dysfunction and infertility
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Levels vary through menstrual cycle. Sample blood between day 2-7 of the cycle (follicular phase)
Tests Test Lutrophin
Name Lutrophin
Units U/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Lutrophin
Magnesium (Mg) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Measured in cases of hypocalcaemia and hypoparathyroidismSerum may not be a good indicator of body stores. Test added if Total and/or corrected Calcium less than 2.20 mmol/L
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Magnesium .
Name Magnesium
Units mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Magnesium
Malarial Parasite Blood films - pH 7.2 (MALARIAL PARASITES) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Blood Film
Name FILM
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Malarial Parasite Blood films - pH 7.2
Manual White Cell Differential (DIFF WBC) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
This is a differential WBC produced by Manual Microscopic Technique
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Baso
Name Basophils
Units x 10^9/L
Blast
Blast
x 10^9/L
Eo
Eosinophils
x 10^9/L
Lym
Lymphocytes
x 10^9/L
Meta
Metamyelocytes
x 10^9/L
Mon
Monocytes
x 10^9/L
Myelo
Myelocytes
x 10^9/L
N.RBC
N.RBC
x 10^9/L
Neut
Neutrophils
x 10^9/L
Prom
Promyelocytes
x 10^9/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Manual W hite Cell Differential
Marrow Trephine Biopsy (TREPHINE) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Histology Pot
Request Form:
Pathology Combined
Specimen:
Marrow
Availabilty:
By arrangement with the Consultant Haematologist
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Marrow Trephine Biopsy
Measles serology () Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Saliva test
Availabilty: Investigation Comments:
Include clinical details and if acute infection or immunity screen
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Measles serology
Metabolic Screen (UMSCR) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine - 5ml minimum
Availabilty:
Routine hours only
Investigation Comments:
Includes screening test for muco-polysaccharides, amino acids, organic acids, and other metabolic abnormalities. Please give clinical details indicating nature of the problems, e.g. acidosis, neurological abnormalities, developmental delay, etc. All abnormal samples are referred to regional centre for further analysis. This may require further samples or completion of more detailed request form
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Cystine/Homocys
Name Urine Cys/Homocys
FeCl test
Urine FeCl test
U.DMB
DMB
U.Keto Acids
Urine Keto Acids
U.MMA
Urine MMA
Units
mg/mmol Cr
Tests
For patient specific reference ranges please refer to printed report or IT systems
Metabolic Screen
Microalbumin (MALB5) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Z10
Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test U.Alb.Conc
Name Urine Albumin
Units mg/L
U.Creat.Conc
Urine Creat.Conc.
mmol/L
UAlb/Cr
Alb/Cre ratio
mg/mmol Cre
Tests
For patient specific reference ranges please refer to printed report or IT systems
Microalbumin
MRSA Screen (MRSA SCREEN) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist / Infection Control
Request Container(s):
Request Form:
Pathology combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Charcoal Transport Swab
Availabilty:
Routinely
Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be placed in the pathology reception fridge.
Short Term Stability
48hrs
Long Term Stability Special Requirements:
Tests Test MRSA Screen
MRSA screen swabs should be obtained from nose, groin and other wounds, skin lesions or invasive devices.. Specimens from other sites will be rejected. Name MRSA Screen
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
MRSA Screen
Mycobacterium Cuture (CAMLiC) (TB CULT) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Tissue, Pus, Fluid, Swab, Urine, Skin
Availabilty:
Routinely
Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
ALL samples and forms to be marked "HIGH RISK"
Tests Test AAFB CULT
Name Culture (CAMLiC) for Mycobacteria
AAFB MICRO
AAFB Microscopy
AAFB SENS
Mycobacterium Sensitivity Testing
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Mycobacterium Cuture (CAMLiC)
Mycoplasma serology (MYPA) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Tested on acute respiratory screen samples.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Mycoplasma serology
Neonatal Bilirubin (BBILI) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Conjugated bilirubin performed on all total bilirubin results greater than 50Âľmol/L
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10°C
Special Requirements:
Tests Test PBIL
Name Paediatric Bilirubin
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Neonatal Bilirubin
Oestradiol (OESTRADIOL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Test used predominantly for the evaluation of fertility problems in adult females.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Depends on stage of menstrual cycle. Sample blood between days 2 - 7 of the cycle (follicular phase)
Tests Test Oestradiol
Name Oestradiol
Units pmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Oestradiol
Opiates (OPIATES) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Opiates
Name Opiates
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Opiates
Osmolality - Plasma (P.OSMO) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Generally requires matched random urine for interpretation
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Calc. OSMO
Name Calculated Osmo.
Units mOsm/Kg
Osmotic gap
Osmotic gap
mOsm/Kg
P.Osmolality
Plasma Osmolality
mOsm/kg H2O
Tests
For patient specific reference ranges please refer to printed report or IT systems
Osmolality - Plasma
Osmolality - Urine (U.OSMO) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours & On Call
Investigation Comments:
Can be useful when compared with the serum osmolality to investigate the concentrating capacity of the kidneys.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Calc. UOSM
Name Calculated Urine Osmo.
Units
U.Osmolality
Urine Osmolality
mOsm/kg H2O
mOsm/Kg
Tests
For patient specific reference ranges please refer to printed report or IT systems
Osmolality - Urine
Paracetamol (PAR.) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Refer to BNF for guidelines
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Important to know time of drug ingestion. Take blood sample 4 hours after overdose
Tests Test Paracetamol.
Name Paracetamol
Units umol/L
Salicylate
Salicylate
mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Paracetamol
Paraquat (PARAQUAT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine - 20ml minimum
Availabilty:
Contact laboratory before collecting sample
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test U.PQT
Name Paraquat Screen
Units (Screening Test o
Tests
For patient specific reference ranges please refer to printed report or IT systems
Paraquat
Parasites (OCP) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Faeces / Parasite for identification / Urine
Availabilty:
Routinely
Investigation Comments:
Send sellotape slide for investigation of Enterobius infestation
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours, samples should be refrigerated at 4-10 C
Short Term Stability Long Term Stability Special Requirements:
Tests Test OCP
If amoebic dysentery is suspected, ensure delivery to the laboratory within 2 hours of passage. If urinary schistosomiasis is suspected, send a sample of terminal urine preferably collected between 10.00 and 14.00. Name Parasite detection/identification
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Parasites
Parathyroid hormone (PTH) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Used to investigate the cause of hyper and hypocalcaemia. Result should be interpreted with the calcium result.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Transport on Ice - Up to 10 minutes
Long Term Stability
Not possible
Special Requirements:
Patient should be bled in hospital and sample must be sent to lab on ice. Needs to be frozen ASAP
Tests Test PTH
Name Parathyroid Hormone
On Ice
Units pmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Parathyroid hormone
Phadiatop (PHAD) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test ALATOP
Name Inhalant Screen
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Phadiatop
Phenobarbitone (PHENOBARBITONE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Take blood sample just before dose (ie trough level)
Tests Test Phenobarb
Name Phenobarbitone
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Phenobarbitone
Phenytoin (PHENYTOIN) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Take blood sample just before dose (ie trough level)
Tests Test Phenytoin
Name Phenytoin
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Phenytoin
Placenta (For Storage) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Histology Pot
Request Form:
Histology WPR2580
Specimen:
Tissue Other specimens may be processed with prior arrangement
Availabilty:
Monday to Friday
Investigation Comments:
Please include on request form the date of delivery. Please note: Placentas are sensitively disposed of once the child has left hospital and one month has passed since the delivery date.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Placenta
Plasma Viscosity (Plasma Viscosity) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
not available at this trust , please contact the lab for information
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test P.Viscosity
Name Plasma Viscosity
Units mPa/s
Tests
For patient specific reference ranges please refer to printed report or IT systems
Plasma Viscosity
Post Mortem Request (PM) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
N/A
Request Form:
Specimen: Availabilty:
Monday to Friday
Investigation Comments:
Opening Hours A service is provided at the DRI mortuary from 8:00 am to 4:30 pm and at the BDGH mortuary from 8:00 to 4:00 pm, on Monday to Friday. Staff availability as well as access for viewing, and the availability of services to undertakers can vary Out of hours mortuary services can be arranged via hospital switchboard
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test
The requesting of a post mortem examination is detailed in the requesting section Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Post Mortem Request
Pregnancy Test (UPT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Mid Stream Urine
Availabilty:
Routine hours only
Investigation Comments:
Urine samples should be fresh early morning specimen. Routine test has a cut-off at 25 IU/L
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test U.Preg.Test
Name Urine Pregnancy
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Pregnancy Test
Pregnancy Test - Bassetlaw (UHCG) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Early morning urine sample
Availabilty: Investigation Comments:
Sensitivity of 25 IU/L
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Early morning urine sample
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Pregnancy Test - Bassetlaw
Products of Conception (POC) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Histology Pot
Request Form:
Histology WPR2580 WPR 20100 Supplementary consent for burial / Cremation for a pregnancy loss under 24 weeks gestation
Specimen:
Pregnancy loss up to 24 weeks gestation
Availabilty:
Monday to Friday
Investigation Comments:
Vac-sac or other container may be placed into the formalin container to retain the sample
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
The request form and consent form are essential requirements prior to sample processing. The patient and a witness (usually a nurse) must sign the consent form (WPR 20100). All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Products of Conception
Progesterone (PROGESTERONE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Test used to assess the probability of ovulation.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Levels vary through menstrual cycle. Blood should be sampled between days 19 -25 of the menstrual cycle (mid-luteal phase)
Tests Test Progesterone
Name Progesterone
Units nmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Progesterone
Prolactin (PROLACTIN) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Levels can be increased by stress. If result greater than 600 mU/L sample will be tested for the presence of macroprolactin
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Prolactin
Name Prolactin
Units mU/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Prolactin
Prostate Specific Antigen (PSA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
For use in diagnosis of prostatic cancer. Not a screening test.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test PSA
Name Prost.Spec.Antigen
Units ng/ml
Tests
For patient specific reference ranges please refer to printed report or IT systems
Prostate Specific Antigen
Protein (UPRO) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Request Form:
Pathology Combined
Specimen:
24hour Urine
Availabilty:
Routine hours only
Investigation Comments:
Estimates protein losses through the kidney and is used in the investigation of patients with renal failure, pre-eclampsia and nephrotic syndrome.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test U.Pro.Conc
Name Urine Protein Conc.
Units
U.Pro.Ex
Urine Protein Excretion
g/24hrs
U.Volume
24 Hr Urine Volume.
Litres
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Protein
Protein Electrophoresis (PROEP) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
For the investigation of multiple myeloma, LPD, Immunodeficiency, Paraprotein Neuropathy
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
An early morning urine sample should also be sent for Bence Jones Protein analysis
Tests Test Albumin.
Name Albumin
Units g/L
Part of LFT and Bone profiles
Globulin.
Globulin
g/L
Ig Monoclone
Monoclonal Ig
g/L
IgA.
Immunoglobulin A
g/L
IgG.
Immunoglobulin G
g/L
IgM.
Immunoglobulin M
g/L
Mon.Isotype.
Monoclonal Isotype
Pro.Electro.
Pro.Electrophoresis
T.Protein.
Total Protein
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Protein Electrophoresis
Prothrombin time including INR (PROTHROMBIN TIME) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate Must be filled to the blue line on the side of the tube Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Prothrombin time including INR
Pus, Fluid or Tissue (SWAB) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Swab
Availabilty:
Routinely
Investigation Comments:
Pus is preferable to a swab and should be sent whenever possible except when in tiny amounts.Optimally collected before antimicrobial therapy started. Joint fluids requiring examination for crystals should be sent to Histopathology, with a separate sample to Microbiology for culture as necessary.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be placed in the pathology reception fridge.
Short Term Stability Long Term Stability Special Requirements:
DO NOT place sample in formalin.
Tests Test Culture
Name Routine Culture
Gram
Direct Gram Film
Swab Sens
Antimicrobial Sensitivty Testing
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Pus, Fluid or Tissue
Red Blood Cell Folate (RBC FOLATE) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test RCF
Name Red Cell Folate
Units ug/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Red Blood Cell Folate
Reducing Substances - Faecal (F.RED) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Faeces
Request Form:
Pathology Combined
Specimen:
Faeces
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test F.Reducing Subst.
Small fresh sample required. Send to laboratory immediately Name F.Reducing Subst.
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Reducing Substances - Faecal
Reducing Substances - Urine (U.RED) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Mid Stream Urine
Availabilty:
Routine hours only
Investigation Comments:
Positive results will be followed up by sugar chromatography
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
-20째C
Special Requirements:
Fresh sample must be provided
Tests Test
Name Reducing Substances
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Reducing Substances - Urine
Respiratory syncytial virus (RSV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Nasopharyngeal aspirate
Availabilty: Investigation Comments: Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Respiratory syncytial virus
Reticulocytes - Automated (RETICULOCYTES) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test RBC
Name Red Blood Cells
Units x 10^12/L
Reticulocytes
Reticulocyte Count
x 10^9/L
RETP
Reticulocyte Percent
%
Tests
For patient specific reference ranges please refer to printed report or IT systems
Reticulocytes - Automated
Reticulocytes - Manual (RETICS) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test RBC
Name Red Blood Cells
RBCS
Red Blood Cells
RETICULOCYTES:
RETICULOCYTE COUNT.
RTX
RETICS
Units x 10^12/L 10^9/l
Tests
For patient specific reference ranges please refer to printed report or IT systems
Reticulocytes - Manual
Rheumatoid Antibodies (RA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test RF
Name Rheumatoid Factor
Units IU/ml
Tests
For patient specific reference ranges please refer to printed report or IT systems
Rheumatoid Antibodies
Rubella serology (RUB) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Rubella IgG performed as screen to detect immunity. IgM to detect infection. Please indicate if patient is pregnant and gestation with contact history.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Please indicate if patient is pregnant and gestation with contact history. Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Rubella serology
Save Serum (SAVE) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Specimen:
Pathology combined
Venous Blood
Availabilty: Investigation Comments:
Sample taken following "needle stick" injury. Saved for long term storage.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Save Serum
Semen post vasectomy (Post Vas) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile universal Request Form:
Histology WPR2580
Specimen:
Post vasectomy semen sample - Whole ejaculate should be collected. If the whole sample is not collected it is deemed unsuitable for further investigations and is discarded Other specimens may be processed with prior arrangement
Availabilty:
Monday, Tuesday and Thursday between 9.00 and 12.00 at BDGH and DRI
Investigation Comments:
Samples must be delivered to the laboratory within 4 hours of production Patients are required to produce two clear samples (i.e. no spermatozoa seen) following vasectomy at pre determined intervals. If two clear samples are provided then the results are made available following the second sample. If either sample shows the presence of spermatozoa then further samples are required until two clear consecutive samples are produced.
Storage Requirements:
Following production the sample should be kept warm by placing the container in a pocket close to the body and delivered to the laboratory as soon as possible.
Short Term Stability
Ambient Temperature
Long Term Stability
Not possible
Special Requirements:
The patient is required to complete additional paperwork on arrival at the laboratory. Please deliver the sample to Histopathology reception at DRI and Pathology reception at BDGH
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Semen post vasectomy
Seminal Fluid for Infertility Investigations (Infertility) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sample must reach the laboratory in under 2 hours Request Form:
Histology Request form
Specimen:
Semen
Availabilty:
Monday to Friday between 9.00 and 3.00 at BDGH and DRI
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability Special Requirements:
Tests Test
Name The laboratory only receives these
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Seminal Fluid for Infertility Investigations
Serum Folate (FOLATE) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test FOL
Name Folic Acid Assay
Units ug/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Serum Folate
Sex hormone-binding globulin (SHBG) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Measured in conjunction with testosterone to calculate free androgen index (FAI)
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test FAI
Name Free Androgen index
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Sex hormone-binding globulin
Sickle Cell Test (SICKLE TEST) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
please advise the laboratory of impending anathaesia/surgery
Tests Test HBS
Name Sickle Test for Haemoglobin S
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Sickle Cell Test
Skin scrapings, hair and nail samples for Mycology (MYCM) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Mycology transport c
Sterile Universal Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Skin scrapings, nail, or hair
Availabilty:
Routinely
Investigation Comments:
Interim report issued with microscopy result. Full culture result may take one month or longer. Samples optimally collected before antifungal therapy.
Storage Requirements:
Store at room temperature.
Short Term Stability Long Term Stability Special Requirements:
Swab skin and nails with 70% alcohol before collection. Skin scrapings best taken from outer edge of lesion.Specify toe or finger nail, include material from any discoloured or dystrophic parts cut as far back as possible through the entire thickness - include any crumbly material. Hair should be plucked out and skin scales included.
Tests Test KOH
Name Direct microscopy for fungal elements
Mycology cult
Culture for fungi, yeasts and moulds
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Skin scrapings, hair and nail samples for Mycology
Sperm Antibodies (SPA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Infertility
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Sperm Ab
Name Sperm Antibody:
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Sperm Antibodies
Split Bilirubin (SBIL) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Also known as conjugated bilirubin. Conjugated bilirubin performed on all total bilirubin results greater than 50Âľmol/L
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10°C
Special Requirements:
Tests Test C.Bilirubin
Name C.Bilirubin
Units
T.Bilirubin
T.Bilirubin
umol/L
umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Split Bilirubin
Sputum - Cytology (Sputum) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile universal Request Form:
Histology WPR2580
Specimen:
Sputum Other specimens may be processed with prior arrangement
Availabilty:
Mon to Fri - sample to arrive at DRI before 4.00pm
Investigation Comments:
Samples are only accepted from chest physicians
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Ambient Temperature
Special Requirements:
All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Sputum - Cytology
Sputum - Microbiology () Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal Sterile Universal Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Expectorated Sputum
Availabilty:
Routinely
Investigation Comments:
Optimally collected before antimicrobial treatment started. Include relevant clinical details. If Cystic Fibrosis patient this MUST BE stated on request form.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours, samples should be placed in the pathology reception fridge.
Short Term Stability
48 hours
Long Term Stability Special Requirements:
Expectorated sputum, NOT saliva, should be collected. Please indicate if Mycobacterial culture is required and send 3 successive early morning samples labelled with DANGER OF INFECTION stickers.
Tests Test Sputum Cult
Name Routine bacterial culture
Sputum Sens
Routine antimicrobial sensitivity testing
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Sputum - Microbiology
Swabs (SWAB) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Swab Swab in transport medium Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Charcoal Transport Swab
Availabilty:
Routinely
Investigation Comments:
Optimally collected before antimicrobial treatment started. Include relevant clinical details. Collection of pus or exudate is always preferable to swabs except when in tiny amounts then sample the deepest part of the wound
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours, samples should be placed in the pathology reception fridge.
Short Term Stability
48 hours
Long Term Stability Special Requirements:
Tests Test Swab Sens
Important to indicate site and nature of lesion. Fine wire pernasal swabs are available for the diagnosis of Bordatella pertussis. For MRSA screen, swabs should be obtained from nose, groin and other wounds, skin lesions or invasive devices. Name Routine antimicrobial sensitivity testing
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Swabs
Synovial fluid (Synovial fluid) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Heparin
Request Form:
Histology WPR2580
Specimen:
Synovial Fluid Other specimens may be processed with prior arrangement
Availabilty:
Mon to Fri - sample to arrive at DRI before 4.00pm
Investigation Comments:
Samples received in universal containers will be processed but are considered sub optimal. Samples received in cytospin collection fluid (green fluid) or formalin will not be processed.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10°C
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Only one request form is required, listing specimens clearly. Ensure left and right samples from the same patient are clearly labelled. All high risk specimens should be clearly marked â&#x20AC;&#x2DC;Danger of infectionâ&#x20AC;&#x2122; on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Synovial fluid
Syphilis serology (SYPH) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Include clinical details
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Syphilis serology
Testosterone (TESTO) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Useful test for assessing androgen function in men and women. Sex hormone binding globulin will be measured on all female testosterone requests.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test FAI
Name Free Androgen index
Units
Testosterone
Testosterone
nmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Testosterone
Thrombophilia Screen (THROMB.SCREEN) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
Citrate
EDTA
Citrate x 4,EDTA, SST Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature - 8 hours maximum
Long Term Stability
Tests
Special Requirements:
Tests Test APC (V-CORRECTED)
Name APC-R ratio (V-Corrected)
APC RATIO
APC Resistance ratio
APC RATIO.
APC Resistance ratio
ATIII AG
Antithrombin III Antigen
IU/ML
ATIII CHROMO
Antithrombin III Chromogenic
IU/ML
ATIII.CHROMO.
Antithrombin III Chromogenic
IU/ML
FV LEIDEN
Factor V Leiden defect
PLASMGN.AG.
Plasminogen Antigen
U/ML
PLASMGN.CHR.
Plasminogen Chromogenic
U/ML
PRO C.CHROMO
Protein C Chromogenic
IU/ML
PRO.C AG
Protein C Antigen
IU/ML
PRO.C CHROM
Protein C Chromogenic
IU/ML
PRO.S ACTIVITY
Protein S Activity
IU/ML
PRO.S FREE AG
Protein S Free Antigen
IU/ML
PRO.S TOTAL AG
Protein S Total Antigen
IU/ML
Units
For patient specific reference ranges please refer to printed report or IT systems
Thrombophilia Screen
Thyroid Antibodies (TAB) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Found in patients with Grave's disease (60%), Hashimoto's (90%) and primary myxoedema
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Anti-TPO
Name Anti-Thyroid Peroxidase:
Units U/ml
Tests
For patient specific reference ranges please refer to printed report or IT systems
Thyroid Antibodies
Thyroid Function Test (TFT) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Thyroid function test includes measurement of TSH and free T4
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test FT4
Name Free T4
Units pmol/L
TSH
TSH
mU/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Thyroid Function Test
Total Serum IgE (IGE) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Preliminary screen as part of Allergen Specific IgE. A normal total IgE does not exclude allergy, nor does a raised value prove allergy
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test IgE
Name Serum IgE:
Units kU/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Total Serum IgE
Toxoplasma serology (REF) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty: Investigation Comments:
Screen for previous exposure to Toxoplasma.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be refrigerated.
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Toxoplasma serology
Troponin T (TROPONIN) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Heparin
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Blood should be taken at least 12 hours post onset of chest pain Haemolysed samples will not be assayed
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Troponin I
Name Troponin I
Units ug/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Troponin T
Urate - Serum (UA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
Raised in various conditions including gout, renal failure & toxaemia of pregnancy
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability Special Requirements:
Tests Test Urate
Name Urate
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Urate - Serum
Urate - Urine (UUA) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
24hr Urine
Request Form:
Pathology Combined
Specimen:
24hour Urine
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
Specimens over 12 hours may be rejected
Special Requirements:
Tests Test U.Cr Exc
Name Urine Creat.Excretion
Units mmol/24hr
U.Creat.Conc
Urine Creat.Conc.
mmol/L
U.Urate.Conc
Urine Urate Conc.
mmol/L
U.Urate.Ex
Urine Urate Excretion
mmol/24hr
U.Volume
24 Hr Urine Volume.
Litres
Tests
For patient specific reference ranges please refer to printed report or IT systems
Urate - Urine
Urea and Electrolytes - U&E (ELU) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
Available
Special Requirements:
Tests Test Creatinine
Name Creatinine
Units umol/L
eGFR
eGFR
mL/min/1.73^2
This is only included with GP requests. For more details and a useful calculator, visit http://www.renal.org or http://www.renal.org/eGFRcalc/GFR.pl for the eGFR Calculator
Haemol
Haemolysis index
Potassium
Potassium
mmol/L
Sodium
Sodium
mmol/L
Urea.
Urea
mmol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Urea and Electrolytes - U&E
Urine - Cytology (Cytology) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile universal Request Form:
Histology WPR2580
Specimen:
Urine
Availabilty:
Mon to Fri - sample to arrive at DRI before 4.00pm
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10°C
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Only one request form is required, listing specimens clearly. All high risk specimens should be clearly marked ‘Danger of infection’ on both form and pot.
Tests Test
Name
Units For patient specific reference ranges please refer to printed report or IT systems
Urine - Cytology
Urine Culture (URINE CULTURE) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
Universal
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Urine
Availabilty:
Routinely
Investigation Comments:
Specimens greater than 24hrs or in non-sterile containers will be rejected.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be placed in the pathology reception fridge.
Short Term Stability Long Term Stability Special Requirements:
A midstream sample of urine should be collected and transported to the laboratory without delay, otherwise refrigerate at 4C for up to 24 hours. Catheter specimens should be collected only if the patient is pyrexial or systemically unwell. For Mycobacteria culture collect 3 early morning samples each comprising two full sterile universal containers
Tests Test
Name
Units
Epithelial cell count
Squamous epithelial cell count
per hpf
Others
Detection of Yeasts or Granular casts (not
Red cell count
RBC count
Urine cult
Urine culture (routine)
Urine Sens
Urine sensitivity testing (routine)
White cell count
WBC count
per hpf
per hpf
Tests
For patient specific reference ranges please refer to printed report or IT systems
Urine Culture
Urine Drug Screen (URINE DRUG) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine - 5ml minimum
Availabilty:
Routine hours only
Investigation Comments:
Require another 15ml if amphetamine or opiate positive. Screening test - Confirmation of 'Positive' results is not available on site.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability Special Requirements:
Tests Test Amphetamines
Name Amphetamines
Amphetamines Class
Amphetamine Class
Barbiturates
Barbiturates
Benzodiazepines
Benzodiazepines
Cannabinoids
Cannabinoids
CocaineMetab
Cocaine metabolites
MethadMetab
Methadone metabolites
Methadone
Methadone
Opiates
Opiates
Propoxyphene
Propoxyphene
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Urine Drug Screen
Urine Elecrophoresis (U.EP) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology combined Min 5ml, preferred 10 ml
Specimen:
Early morning Urine
Availabilty:
Routine hours only
Investigation Comments:
Also known as Bence Jones Protein analysis
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test UEP
Name Urine Protein Electrophoresis
Units
UMONO
Monoclonal Ig
g/L
UPRO
Urine Protein Concentration
g/L
UPRO%
% of Total Urine Protein
%
Tests
For patient specific reference ranges please refer to printed report or IT systems
Urine Elecrophoresis
Urine Protein (UPRO.) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
Universal
Request Form:
Pathology Combined
Specimen:
Random Urine
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability Special Requirements:
Tests Test U.Cr
Name Urine Creatinine conc
U.Pro Cr
Urine Protein / Creatinine ratio
U.Pro.Conc
Urine Protein Conc.
Units
g/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Urine Protein
Valproate (VALPROIC A) Department:
Clinical Biochemistry
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Clinical Biochemist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
Take blood sample just before dose (ie trough level)
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Valproate
Name Valproic Acid
Units umol/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Valproate
Vancomycin Assays (VANCO) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty:
MON-FRI 0900-2000, SAT 0900-1200, OUT OF HOURS - BY APPROVEMEN
Investigation Comments:
Please complete "Assay Request Forms" in full, specific labels for assay samples are available. These can be obtained from Pathology Reception. Assays with incomplete dosing and specimen details will be rejected.
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test Vancomycin
Name Vancomycin
Units mg/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Vancomycin Assays
Vancomycin Resistant Enterococcus (VRE) Screen () Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Microbiologist or Infection Control
Request Container(s):
Swab
Request Form:
Faeces
Pathology combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Charcoal Transport Swab, Faeces or Urine
Availabilty:
Routinely
Investigation Comments:
Please complete "Assay Request Forms" in full, specific labels for assay samples are available. These can be obtained from Pathology Reception. Assays with incomplete dosing and specimen details will be rejected.
Storage Requirements:
Specimens should be sent to the laboratory without delay during normal hours. Outside of normal hours samples should be placed in the pathology reception fridge.
Short Term Stability Long Term Stability Special Requirements:
Tests Test VRE Screen
Name Screen for Vancomycin Resistant
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Vancomycin Resistant Enterococcus (VRE) Screen
Varicella-zoster serology (immunity) (VZV) Department:
Microbiology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
01909 502493 (2493)
Request Container(s):
SST
Request Form:
Pathology Combined When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations that a separate request form is completed to accompany the sample.
Specimen:
Venous Blood
Availabilty:
Contact laboratory for urgent testing
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test
If contact in pregnancy please state gestation with date and nature of contact. Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Varicella-zoster serology (immunity)
Vitamin B12 (VIT B12) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
SST
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours & On Call
Investigation Comments:
If result less than 100 ng/L sample will automatically be tested for Intrinsic Factor antibodies
Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient temperature - 4 to 6 hours
Long Term Stability
4 - 10째C
Special Requirements:
Tests Test B12
Name Vitamin B12 Assay
Units ng/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
Vitamin B12
Washings (Bronchial, Endometrial, Peritoneal) Department:
Histology
Contact:
01302 553130 (3130)
Clinical Contact:
01302 553130 (3130)
Request Container(s):
Universal Sterile universal Request Form:
Histology WPR2580
Specimen:
Washings
Availabilty:
Mon to Fri - sample to arrive at DRI before 4.00pm
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability
Ambient Temperature
Long Term Stability
4 - 10°C
Special Requirements:
If a number of samples are removed from the same patient during a single procedure they should be placed in separate containers and labelled as to their site of origin. Only one request form is required, listing specimens clearly. All high risk specimens should be clearly marked ‘Danger of infection’ on both form and pot.
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
Washings
White Cell CD4/8 Markers (CD4/8) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test
Name
Units
Tests
For patient specific reference ranges please refer to printed report or IT systems
White Cell CD4/8 Markers
White Cell Count - Fluid (WBC COUNT) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments: Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test FL
Name Fluid WBC count
Units x 10^9/L
Tests
For patient specific reference ranges please refer to printed report or IT systems
White Cell Count - Fluid
Zinc Protoporphyrin (ZPP) Department:
Haematology
Contact:
01302 553131 (3131) or 01909 502344 (2344)
Clinical Contact:
Consultant Haematologist
Request Container(s):
EDTA
Request Form:
Pathology Combined
Specimen:
Venous Blood
Availabilty:
Routine hours only
Investigation Comments:
This test may also be requested by lab staff as indicated by other results
Storage Requirements:
Refer to Short Term Stability
Short Term Stability Long Term Stability Special Requirements:
Tests Test ZPP
Name ZINC PROTOPORPHYRIN
Units umol/molHb
Tests
For patient specific reference ranges please refer to printed report or IT systems
Zinc Protoporphyrin
Advice
Advice
Clinical Info Complaints Results
Directorate of Pathology Timing of samples and interpretation for measurement of Carbamazepine. KEY FACTS - Carbamazepine Sample timing - Immediately before taking the dose, at least 5 days after initiation of treatment or dose change.
Therapeutic range â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘
20 - 50 umol/L for single drug use. 17 - 34 umol/L when used in multidrug combination. Expect severe toxicity about 200 umol/L.
Bioavailability of oral dose - Peak plasma concentration typically about 3 Hrs post dose (Highly variable). Metabolism - Carbamazepine is metabolised almost completely to a variety of active & inactive metabolites by the hepatic mixed function oxidase system. Metabolism is induced by Carbamazepine itself, Phenytoin and Phenobarbitone. Initial elimination half time is about 35 Hrs decreasing to about 20 Hrs after a few weeks treatment. Lamotrigine co-administration may inhibit metabolism & precipitate toxicity. Distribution - Carbamazepine diatributes rapidly with a volume of distribution of 0.8 - 1.9 L/Kg. Protein binding - About 75% of circulating Carbamazepinne and metabolites are bound to proteins, therefore there is potential for increase in the free fraction whenever other protein bound drugs are co-administered. Elimination - Urinary excretion of metabolites and conjugated metabolites
Timing of Carbamazepine measurements after starting treatment or a dose change. Carbamazepine is usually commenced gradually over three or four weeks to avoid initial adverse effects during equilibration. These ocurr because carbamazepine induces it's own metabolism. Initial dose is typically 1/4 to 1/3 the final maintainance dose, increasing by 1/4 or 1/3 the full dose per week. The main limitation in monitoring Carbamazepine is the need to ensure stable metabolic activity before measurements are taken this requires at least 5 days after the commencement or last dose change of either carbamazepine or other interacting drug.
Timing of Carbamazepine measurements relative to taking the dose. Remember.Drug concentrations are not stable at any time after the dose unless the required time has elapsed since commencing treatment or the last dose change.
Advice
The concentration of Carbamazepine is most stable and correlates with therapeutic effects close to the time of taking the next dose. Values measured at this time have been used to derive the therapeutic range and this timing should also be used in taking samples to direct changes in dose. Specimens taken substantially before this timing will yield inappropriately high results due to incomplete distribution into peripheral tissues and may result in selection of an inappropriately low dose. Interpretation of results for Carbamazepine. Before interpreting a result check the specimen timing was correct Timing of after a dose change. Timing relative to taking the dose.
Author Title Document No.
Dr Richard Stott Carbamezapine PD-UserHbk-015 ver1.0
Page 1 of 2 22/03/2007
Due to combined effects on metabolism and competition for protein binding, Therapeutic range depends on whether Carbamazepine is used as a single drug or in combination with other drugs. 20 - 50 umol/L for single drug use. 17 - 34 umol/L when used in multidrug combination. Some patients may show adequate therepeutic effects at concentrations below 20 umol/l and there is no indication for increasing the dose in these individuals to achieve levels within the quoted ranges. Toxicity can ocurr within these ranges in some individuals and can probably be avoided by maintaining Carbamazepine levels below 40 umol/L. Expect severe toxicity about 200 umol/L.
Advice
1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Individualizing Drug Therapy. Gross, Townsend, Frank INC, New York. Library of Congress No 8182052 4. Clinical pharmacokinetics of carbamazepine. Clinical Pharmacokinetics 3, 128 (1978)
Author Title Document No.
Dr Richard Stott Carbamezapine PD-UserHbk-015 ver1.0
Page 2 of 2 22/03/2007
Directorate of Pathology Timing of samples and interpretation for measurement of Cyclosporin. This page is divided into sections as follows:• • •
Timing of measurements after starting therapy or a dose change. Timing of measurements relative to taking the dose. Interpretation of results.
KEY FACTS - Cyclosporin •
Cyclosporin is extensively metabolised & assays respond differently to the metabolites. Therapeutic ranges depend on the organ which was transplanted & the assay used & the practice of the transplant centre. All samples are sent to the hospital which was responsible for the original surgery. For new patients, please include details of the transplant centre with the request.
•
Specimens for monitoring treatment of autoimmune disease are sent to Northern General Hospital, Sheffield.
•
Many centres do not return results to us but advise on dose adjustments directly to the requesting physician or patient.
Sample type - Requires whole blood due to cyclosporin accumulating in red cells. Anticoagulant is typically EDTA (Lavender top tube) but King's College Hospital require Li heparin (Green top). Sample timing - Immediately before taking the dose, at least 1 week after initiation of treatment or dose change. Therapeutic range - Depends on the assay used, time since transplantation & organ transplanted. Toxic & therapeutic effects are not well correlated with concentration. Bioavailability of oral dose - 10 - 60% Peak values typically 1 - 8 Hrs post dose. Absorbtion affected by intestinal motility, particularly diarrhoea which can cause marked decline in absorbtion. Reduced bile flow also slows absorbtion. Metabolism - Cyclosporin is metabolised in the liver by the mixed function oxidase system. More than 30 metabolites, some of which are active. Metabolism highly variable with some evidence of diurnal rythmn.Typical elimination half life is 6 Hrs. Metabolites are excreted in bile (less than 1% in urine) and may be re-absorbed. Cyclosporin metabolism is therefore altered by liver disfunction . Distribution - 1.0 - 13.0 l/Kg Extensively distributed, mainly in lipid rich tissues. Timing of Cyclosporin measurements after starting treatment or a dose change. Due to the extensive distribution into fatty tissues steady state is reached after about 1 week in most patients. Some individuals may require longer if particularly obese.
Advice
Timing of Cyclosporin measurements relative to taking the dose. Remember.Drug concentrations are not stable at any time after the dose unless the required time has elapsed since commencing treatment or the last dose change. Due to the variability in absorbtion both between patients and between doses in the same patient, the concentration of Cyclosporin is most stable close to the time of taking the next dose. Values measured at this time have been used to derive the therapeutic range and this timing should also be used in taking samples to direct changes in dose. Specimens taken substantially before this timing wil yield inappropriately high results due to incomplete distribution into peripheral tissues and may result in selection of an inappropriately low dose. To avoid the effects of diurnal variation repeat samples should be taken at the same time of day if possible. Author Title Document No.
Dr Richard Stott Cyclosporin PD-UserHbk-014 ver 1.0
Page 1 of 2 22/03/2007
Interpretation of results for Cyclosporin. Most centres advise on dose adjustments directly on the requesting clinician or patient. This is based on the assumption that specimen timing is correct. Therefore it is essential that those taking the sample use the correct timings Specimens for monitoring treatment of autoimmune disease are sent to Northern General Hospital, Sheffield. Their target concentrations are • 155 ug/L Ulcerative colitis • 100 ug/L for renal transplants. • Cardiac transplant - Initially 300 ug/L decreasing to 200 ug/L. For new patients, it is essential that details of the transplant centre are included with the request. References
Advice
1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Individualizing Drug Therapy. Gross, Townsend, Frank INC, New York. Library of Congress No 8182052 4. NGH target range data was a personal communication by Dr Gray, NGH clinical chemistry Dept. 29/1/1998.
Author Title Document No.
Dr Richard Stott Cyclosporin PD-UserHbk-014 ver 1.0
Page 2 of 2 22/03/2007
Directorate of Pathology Timing of samples and interpretation for measurement of Digoxin. This page is divided into sections as follows: • Common indications for measurement. • Timing of measurements after start of treatment or a dose change. • Timing of measurements relative to taking the dose. • Interpretation of results. • Symptoms, Actions and future measurements in the event of OVERDOSE. You may also want to review the Pharmacy formulary site page about Digoxin and the page about Importance of specimen timing in therapeutic drug monitoring. KEY FACTS - Digoxin Sample timing - At least 6 hours post dose (IV or Oral dosing) and at least1 week after initiation of treatment or dose change (Longer if renal function is abnormal) Can also be measured after 1st maintenance dose if IV loading dose used. Therapeutic range - 1.0 - 2.6 nmol/L Almost always get toxic effects at or above 3.0 nmol/L. Bioavailability of oral dose - 40 - 75% from tablets depending on preparation Up to 80% for Elixir. Lowered by co-administration of drugs which affect GI motility (E.g. Metoclopramide), Malabsorbtion syndromes lower bioavailability. Either may result in sub therapeutic effects from a previously adequate dose. Metabolism - Most patients metabolize less than 20% of dose. About 10% of individuals metabolize significant proportion of dose, yielding active metabolites, which may not be measured. This can be a cause of toxicity despite a 'therapeutic range' result. Distribution - Effectively two compartments - central (Blood, kidney, liver) - Peripheral (Skeletal and cardiac muscle) At equilibrium, peripheral compartment has 15 - 30 times central concentration therefore very significant errors due to sampling too early after dose. Elimination - Excretion via kidneys. Half-life typically 40 hours. Deterioration in renal function leads to increased Half life (up to 100 hrs or more) and is a common cause of toxicity. Creatinine clearance Elimination half life Time to steady state 90 ml/min 1.6 days 6 days 60 ml/min 2 days 8 days 35 ml/min 2.5 days 10 days 15 ml/min 3 days 12 days 5 ml/min 3.2 days 13 days. Common indications for measurement of DIGOXIN. Monitoring of Digoxin is not indicated in the majority of patients on maintenance treatment when a clear therapeutic effect has been obtained.
Advice
Monitoring is valuable in the following circumstances• Poor initial response. Measurement indicates whether the patient is compliant, what concentration the current dose is achieving and indicates how much of an increase in dose is likely to be safe. • Poor response after initial good response. Measurement indicates whether the patient is compliant and may indicate the need for an increased dose. • To decide if continued therapy is required. A patient on long-term digoxin treatment with concentrations less than 1.0 nmol/L is unlikely to deteriorate if digoxin is stopped. • When changing dose of interacting drugs. Adding or removing interacting drugs will alter the therapeutic efficacy of a constant digoxin dose, monitoring will indicate the required dose change to maintain therapeutic benefit. E.g. Diuretics, Quinidine, Metaclopromide. • When renal function is changing. Deteriorating renal function is a common cause of toxicity. Monitoring will result in early warning of changing concentrations and allows appropriate dose adjustment. • Suspected toxicity. Monitoring digoxin may confirm the presence of a toxic level but should be accompanied by investigations (K, Ca, Mg, Creatinine and Thyroid functions to exclude alterations in tissue sensitivity. Timing of DIGOXIN measurements after start of treatment or a dose change. Treatment is usually commenced using the 'Maintenance dose' of digoxin in patients with mild cardiac symptoms. Where rapid onset of symptom control is essential, there will be an initial 'loading dose' (0.75 to 1.0 mg) usually given as an IV infusion over several hours. This achieves the steady state condition very rapidly. The first 'Maintenance dose' is given the appropriate time later and monitoring can commence after this dose. In treatment with 'Maintenance' doses (Typically 125 - 250 micrograms twice daily), the elimination half-life of digoxin regulates the accumulation between doses. Author Title Document No.
Dr Richard Stott Digoxin PD-UserHbk-016 ver1.0
Page 1 of 5 22/03/2007
If there is no loading dose, between three and five half lives are required before the difference between current and 'steady state' concentrations becomes less than the assay imprecision (Typically 5 - 10% CV). In normal individuals the half-life is 40 hours and therefore a period of at least1 week should be allowed before checking the concentrations achieved. Caution Renal function leads to increased half-life (100 hrs or more in Anuria) which can prevent steady state being achieved within a practical time. Creatinine clearance Elimination half life Time to steady state 90 ml/min 1.6 days 6 days 60 ml/min 2 days 8 days 35 ml/min 2.5 days 10 days 15 ml/min 3 days 12 days 5 ml/min 3.2 days 13 days This timing limitation applies equally to both increases and decreases in dose so monitoring in renal failure patients can be problematical. Timing of DIGOXIN measurements relative to taking the dose. Digoxin distribution after an IV dose closely matches a two compartment mathematical model. The central compartment represents rapidly equilibrating tissues with good blood supply (Blood, kidney, liver) while the peripheral compartment represents less well perfused tissues (Skeletal and cardiac muscle). We are taking the sample from the central compartment whereas the response to digoxin occurs in the other compartment; therefore the concentrations in the two compartments must reach equilibrium before the sample is taken. This is essentially complete by 6 hours after the dose (Oral or IV) and therefore the sample can be taken any time between 6 hours and the next dose. Digoxin is rapidly absorbed and therefore the kinetics of oral dosing is similar to IV. The Distribution phase of digoxin imposes the limitation on sample timing after the doses. Caution At equilibrium, the peripheral compartment has 15 - 30 times the central concentration therefore very significantly increased concentrations will occur due to sampling too early after dose. Any dose change based on these measurements could result in sub therapeutic concentration and return of the patient's original symptoms.
Advice
Interpretation of results for DIGOXIN. • •
-Before interpreting a result check the specimen timing was correct -Therapeutic ranges for Digoxin are poorly defined. The concentration does correlate well with certain measurable cardiac parameters (ECG results and systolic time intervals) but these do not relate closely to overall therapeutic outcome. Little or no therapeutic effect is seen at digoxin levels of less than 1.0 nmol/L. Toxicity almost always occurs above 3.0 nmol/L. The generally accepted 'Therapeutic target' is 1.0 - 2.6 nmol/L. Some patients may benefit from carefully increasing the dose to give concentrations above 2.6 nmol/L if no adverse effects become evident.
•
The sensitivity of myocardium to digoxin is altered by several co-existing factors, which hamper the interpretation of digoxin levels. 1. Potassium Hypokalaemia is associated with an enhanced response and is the commonest cause of toxic symptoms. Potassium should always be measured when toxicity is suspected and any hypokalaemia corrected prior to adjusting the digoxin dose. this may resolve the apparent toxicity. Digoxin levels cannot be interpreted in the presence of hypokalaemia. 2. Calcium and Magnesium Hypercalcaemia and hypomagnesaemia are also associated with increased sensitivity and should be corrected prior to monitoring digoxin. 3. Thyroid function Hypothyroidism increases sensitivity to digoxin and Hyperthyroidism decreases it, making interpretation difficult in patients with thyroid disease. 4. Age. Elderly patients are more sensitive to digoxin than young patients.
•
Caution - Pregnancy, Renal failure and liver failure.
Author Title Document No.
Dr Richard Stott Digoxin PD-UserHbk-016 ver1.0
Page 2 of 5 22/03/2007
•
There are a number of 'Digoxin like factors' which accumulate in these conditions. These may cross react in some assays (But not all) and can produce apparently Therapeutic values on patients who are not taking digoxin or 'Toxic' concentrations in a well controlled patient without toxic symptoms. The identity of these factors is not well known and a particular digoxin assay may be affected by any combination of the conditions. Concentrations must be carefully interpreted in conjunction with clinical assessment of the patient's symptoms
Causes, Symptoms and Treatment in the event of OVERDOSE. • •
Causes of Digoxin OVERDOSE. Toxic effects are common and can be Severe or Fatal. Diagnosis should depend on a careful clinical examination and should not be entirely based on digoxin measurement as toxic symptoms may occur within the therapeutic range and a few patients may require apparently 'Toxic' concentrations for optimal symptom relief. Common causes of toxicity include: o Metabolic abnormalities. o Renal failure (Especially gradual onset). o Effects of other drugs. Metabolic abnormalities. Response to a fixed digoxin concentration is dependent on other biochemical parameters including Potassium, Calcium and Magnesium. Symptoms of toxicity may appear or be exacerbated when the patient has co-existing hypokalaemia, Hypercalcaemia, Hypomagnesaemia or hypothyroidism. All of these conditions increase the sensitivity of the myocardium to digoxin. This can result in 'Toxic' symptoms when the digoxin concentration is within the 'Therapeutic' range. Treatment with non potassium sparing diuretics is probably the most common cause of toxicity in a previously stable patient. In most patients with increased sensitivity to digoxin, the underlying abnormality can be treated rapidly and the 'Digoxin toxicity' will resolve without requiring a dose change. Renal failure. Renal excretion of digoxin is the main elimination route for parent drug and active metabolites. In normal individuals the half life is 40 hours and the individual dose is likely to have been established under these conditions. Any significant deterioration in renal function will extend the elimination half-life resulting in clearance of less of each dose before the next dose is taken. Creatinine clearance Elimination half life Time to steady state 90 ml/min 60 ml/min 35 ml/min 15 ml/min 5 ml/min
1.6 days 2 days 2.5 days 3 days 3.2 days
6 days 8 days 10 days 12 days 13 days
Advice
Therefore failing renal function leads to a gradual increase in digoxin concentration throughout the dose - dose cycle. Large doses are commonly divided into a twice daily regimen to minimize the occurrence of toxic symptoms therefore the initial onset of extra symptoms will be gradual and will be observed for a progressively longer period after each dose. These become continual as the renal failure (and concentration increase) becomes more severe. By the time the patient becomes anuric, the elimination half life will be increased to 100 hrs or more producing a several fold increase in the digoxin concentrations at all times and there may be a very large excess of digoxin accumulated in the tissues. Renal failure also introduces a potential confounding effect as there are a number of 'Digoxin like factors' which accumulate in renal failure (Also found in pregnancy and liver failure). These may cross react in some assays (But not all) and can produce apparently 'Toxic' concentrations in a well controlled patient without toxic symptoms. Caution Symptoms may be exacerbated where the patient is also treated with non potassium sparing diuretics as this can result in hypokalaemia and increased sensitivity of the myocardium to digoxin. This can result in 'Toxic' symptoms when the digoxin concentration is within the 'Therapeutic' range. Most treatments which resolve the renal failure (and / or rectify the resulting metabolic disturbances) will be highly effective in reducing the toxicity of digoxin by improving the clearance. Resolution of the renal failure will rapidly correct the toxicity allowing the patient to continue on the previous dose, however a dose reduction will often be required until adequate renal function can be restored. Haemodialysis is effective in treating moderate toxicity due to renal failure but it mainly acts by ensuring normal tissue sensitivity via avoiding or correcting Hypokalaemia, Hypercalcaemia and Author Title Document No.
Dr Richard Stott Digoxin PD-UserHbk-016 ver1.0
Page 3 of 5 22/03/2007
Hypomagnesaemia. It is not possible to remove significant amounts of digoxin by dialysis due to the relatively large amounts of digoxin contained in the extravascular compartment (Volume of distribution is 4 - 10 L/Kg). Effects of other drugs. A number of drugs alter the handling of digoxin by changing absorption and excretion of the parent compound. Treatment with or changes in dose of these drugs may result in alterations in availability of digoxin with potentially 'Toxic' concentrations resulting. 1. Starting diuretics (Non-K sparing). 2. Starting Antimalarials (e.g. Quinine, Chloroquine),NSAIDs, Anti arrhthmics (e.g. Amiodarone, Quinidine) etc 3. Stopping drugs, which increase GI motility/prevent absorption. (e.g.. Metaclopramide, Cholestyramine). Giving conventional therapeutic doses of drugs in these categories can result in doubling or greater increase in digoxin concentrations with potentially toxic effect. In these situations monitoring of digoxin after the change (or before and after) may enable alteration in the dose of digoxin to maintain the previous symptom control despite the alteration in digoxin handling. Symptoms of Digoxin OVERDOSE. • Loss of appetite, Anorexia (Experienced by 60% of individuals with toxic levels) Nausea (60%) and vomiting (50%). 'Maintenance' doses are often given twice daily to minimize these symptoms. • Giddiness. • Visual disturbance including colour distortion to green / yellow (Less than 15%). • Increased Urine / Faecal frequency (6%). • Cardiac Arrhythmia / Conduction defects (70 -95% of toxic individuals). Sinus bradicardia, Ventricular extrasystole, First / Second degree AV block are common. Ventricular / Atrial tachicardia less common. Treatment of Digoxin OVERDOSE. The most common causes of 'Toxic' symptoms are readily correctable metabolic abnormalities including Hypokalaemia, Hypercalcaemia, Hypomagnesaemia and Hypothyroidism. Where these conditions exist, the fastest treatment for digoxin toxicity is to correct the metabolic abnormality. The symptoms will normally resolve rapidly and the patient can continue with the previous digoxin dose. Treatment of chronic digoxin overload is more difficult due to the fairly high volume of distribution (4 - 10 L/Kg depending on renal function), therefore the majority of the digoxin is located in the peripheral tissues. This makes it difficult to remove substantial amounts using Haemofiltration, Haemoperfusion or dialysis. Patients with mild symptoms can often be treated by cessation of the digoxin dose, correction of any electrolyte abnormalities and allowing the excretion of the excess via the kidneys. In the event of massive accumulation of digoxin requiring rapid treatment, there is a specific antidote. 'Digibind' is a fragment of an antibody raised against digoxin, this remains in the circulation and binds all of the free digoxin. This results in a blood free digoxin concentration of 0 and promotes rapid movement of digoxin out of the tissues. The digoxin recovered in this way is then rapidly excreted via the kidneys. There are several problems with this therapy 1. Cost. 2. The dose must be carefully calculated according to the amount of digoxin in the patient. Monitoring may be required prior to giving the dose. 3. Digibind persists in the patient for a considerable time. This makes it difficult to re-establish digoxin therapy. 4. Digibind in the sample prevents measurement of digoxin using most assays (Depending on the method, results range from 0 up to 100 fold the normal). This makes it impossible to monitor the treatment and difficult to re-establish digoxin treatment. Please indicate any Digibind treatment on the clinical details section of the request forms. 5. Digibind administration may also result in the patient producing antibodies against Sheep proteins, these could produce immunological problems if second treatments were required and have the potential to interfere in other immunoassays.
Advice
Interpretation of results for DIGOXIN. Therapeutic ranges are poorly defined. The concentration does correlate well with certain measurable cardiac parameters (ECG results and systolic time intervals) but these do not relate closely to overall therapeutic outcome. Little or no therapeutic effect is seen at digoxin levels of less than 1.0 nmol/L and toxicity almost always occurs above 3.0 nmol/L. The generally accepted 'Therapeutic target' is 1.0 - 2.6 nmol/L although some patients may benefit from carefully increasing the dose to give concentrations above 2.6 nmol/L if no adverse effects become Author Title Document No.
Dr Richard Stott Digoxin PD-UserHbk-016 ver1.0
Page 4 of 5 22/03/2007
evident. The sensitivity of myocardium to digoxin is altered by several co-existing factors, which hamper the interpretation of digoxin levels. 1. Potassium Hypokalaemia is associated with an enhanced response and is the commonest cause of toxic symptoms. Potassium should always be measured when toxicity is suspected and any hypokalaemia corrected prior to adjusting the digoxin dose. this may resolve the toxicity. Digoxin levels cannot be interpreted in the presence of hypokalaemia. 2. Calcium and Magnesium Hypercalcaemia and hypomagnesaemia are also associated with increased sensitivity. 3. Thyroid function Hypothyroidism increases sensitivity to digoxin and Hyperthyroidism decreases it, making interpretation difficult in patients with thyroid disease. 4. Age Elderly patients are more sensitive to digoxin than young patients. Caution - Pregnancy, Renal failure and liver failure There are a number of 'Digoxin like factors' which accumulate in these conditions. These may cross react in some assays (But not all) and can produce apparently Therapeutic values on patients who are not taking digoxin or 'Toxic' concentrations in a well controlled patient without toxic symptoms. The identity of these factors is not well known and a particular digoxin assay may be affected by any combination of the conditions. Concentrations must be carefully interpreted in conjunction with clinical assessment of the patient's symptoms. References
Advice
1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Digoxin., by - P. Keys. In - Individualizing Drug Therapy. Vol. 3. (Taylor, W.J. and Finn, A.L. Editors) Gross Townsend, Frank INC, New York. Library of Congress No 81-82052
Author Title Document No.
Dr Richard Stott Digoxin PD-UserHbk-016 ver1.0
Page 5 of 5 22/03/2007
Directorate of Pathology Timing of samples and interpretation for measurement of Lamotrigine. This page is divided into sections as follows:â&#x20AC;˘ Timing of measurements after starting therapy or a dose change. â&#x20AC;˘ Timing of measurements relative to taking the dose. â&#x20AC;˘ Interpretation of results. You may also want to review the Pharmacy formulary site page about anticonvulsants and the page about Importance of specimen timing in therapeutic drug monitoring. KEY FACTS - Lamotrigine Samples are sent to Regional Toxicology Lab. Dudley Rd Hospital. Birmingham. Tel 0121 507 4135 The therapeutic ranges quoted are derived from their data and any queries should be directed to the laboratory performing the analysis. Sample timing - Immediately before taking the dose, at least 5 days after initiation of treatment or dose change (Normal individual on a Lamotrigine only). 15 days if co-administered with Valproate. Therapeutic range - 3.9 - 15.6 umol/L Levels much higher than this are often required for adequate control and are generally well tolerated. Levels up to 60 umol/L may be appropriate. Bioavailability of oral dose - > 95% absorbed. Volume of distribution 1.2 L/Kg. Peak concentrations about 3 Hrs post dose. Metabolism - >90% dose metabolidsed by conjugation. Follows first order kinetics with half life around 24 Hrs. Enzyme inducing drugs (eg Phenytoin & Carbamazepine) reduce the half life to about 15 Hrs. Valproate extends to about 60 Hrs. Lamotrigine may precipitate Carbamazepine toxicity by inhibiting metabolism. Timing of Lamotrigine measurements after starting treatment or a dose change. The half life of elimination of lamotrigine is normally 24 Hrs so a period of 5 days should be allowed between commencing treatment or changing dose before any monitoring of levels is attempted. In the case of treatment with Valproate, this time must be extended to 15 days because of the prolonged elimination time. Coadministarion with both inhibitory & stimulatory drugs gives half life about 24 Hrs. Withdrawal of the inducing drug from such a mix results in marked increases in Lamotrigine & Valproate. Unless checking for potentially toxic levels, the same timing criteria must be applied to routine monitoring of any other anticonvulsants in the regimen. Timing of Lamotrigine measurements relative to taking the dose. Remember: Drug concentrations are not stable at any time after the dose unless the required time has elapsed since commencing treatment or the last dose change, this may be a considerable time where multiple drugs are co-administered. The concentration of Lamotrigine and other anticonvulsants is most stable and correlates with therapeutic effects close to the time of taking the next dose. Values measured at this time have been used to derive therapeutic ranges and this timing should also be used in taking samples to direct changes in dose. Specimens taken substantially before this timing will yield inappropriately high results due to incomplete distribution into peripheral tissues and may result in selection of an inappropriately low dose. Interpretation of results for Lamotrigine.
Advice
Before interpreting a result check the specimen timing was correct Remember: Drug concentrations are not stable at any time after the dose unless the required time has elapsed since commencing treatment or the last dose change. The concentration of Lamotrigine is most stable and correlates with therapeutic effects close to the time of taking the next dose. Values measured at this time have been used to derive the therapeutic range and this timing should also be used in taking samples to direct changes in dose. Specimens taken substantially before this timing will yield inappropriately high results due to incomplete distribution into peripheral tissues and may result in selection of an inappropriately low dose. Author Title Document No.
Dr Richard Stott Lamotrigine PD-UserHbk-017 ver1.0
Page 1 of 2 22/03/2007
The use of lamotrigine as adjunctive therapy means that levels & clinical effects may be influenced by other anticonvulsants. All anticonvulsants in the regimen should be monitored at the same time and all results used in any decision about dose adjustment. Therapeutic range - 3.9 - 15.6 umol/L Levels much higher than this are often required for adequate control, Levels up to 60 umol/L may be appropriate. Levels of 50 - 100 umol/L have been encountered in patients with refractory siesures without documented adverse effects. There is no good trial data supporting lamotrigine therapeutic range. This is partially due to the difficulty in defining adequate siesure control due to Lamotrigine when used as adjunctive therapy (Often with more than 1 other anticonvulsant) in patients who have proven difficult to control with other drugs. There is little evidence of correlation of side effects with any particular Lamotrigine concentrations. References
Advice
1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Individualizing Drug Therapy. Gross, Townsend, Frank INC, New York. Library of Congress No 8182052 4. Rambeck & Wolf. Lamotrigine clinical pharmacokinetics. Clin. Pharmacokinet 1993, 25; 433 - 443. 5. Brodie. Lamotrigine. Lancet 339: 1397 - 1400. 1992. 6. Patsalos, P.N. (1999) New antiepileptic drugs. Ann. Clin. Biocem. 36, 10 - 19.
Author Title Document No.
Dr Richard Stott Lamotrigine PD-UserHbk-017 ver1.0
Page 2 of 2 22/03/2007
Directorate of Pathology Timing of samples and interpretation for measurement of Lithium. This information page is divided into sections as follows:â&#x20AC;˘ Timing of measurements relative to taking the dose. â&#x20AC;˘ Interpretation of results. â&#x20AC;˘ Symptoms, Actions and future measurements in the event of OVERDOSE. You may also want to review the Pharmacy formulary site page about Lithium and the page about Importance of specimen timing in therapeutic drug monitoring. Department of Psychiatry Guidelines which cover Lithium use. KEY FACTS - Lithium. Sample timing - At least 12 hours post dose. At least 5 days to 2 weeks after initiation of treatment or dose change, Longer time for older patients (Assumes Normal renal function). Therapeutic range - 0.5 - 1.0 mmol/L Bioavailability of oral dose - 100% within 2 Hrs from conventional preparations. Massive doses of sustained release preparations can result in recurrent toxicity over several days due to continued absorbtion. Metabolism - Lithium is not metabolised. Distribution - Lithium distributes into total body water (0.6 L/Kg) reaching equilibrium within 24 hours after the first dose. Elimination - Excretion via kidneys. About 80% filtered in glomerulus and reabsorbed in proximal tubule. Half life ranges from 18 hours in young patients to 36 Hrs in older patients with intact renal function. Clearance depends on GFR and proximal tubule reabsorbtion. Handling is similar to Sodium therefore reclamation is increased in dehydration or sodium depletion. At toxic levels, Li can induce nephrogenic diabetes insipidus, resulting in increased free water loss and dehydration. This induces a vicious circle of decreased Li clearance, increased free water loss & worsening dehydration. Non-steroidal anti inflammatory drugs, Thiazide and loop diuretics can reduce Li excretion precipitating toxicity. There are specific guidelines issued by the department of Psychiatry which cover Lithium use. These should be consulted before commencing therapy as they include pre treatment assesments, contraindications to lithium therapy, actions in the event of side effects and long term monitoring arrangements. Timing of Lithium measurements after commencing treatment or a dose change. Between three and five half lives are required before the difference between current and 'steady state' concentrations is less than the assay imprecision (Typically 5 - 10% CV). In normal individuals the half life is 18 to 36 hours and therefore a period of 5 days to 2 weeks should be allowed after commencement of treatment or a substantial dose change before checking the concentrations achieved. Timing of Lithium measurements relative to taking the dose. Li levels are relatively stable by 12 hours after the dose (Effectively trough concentrations). This timing was used in deriving the therapeutic ranges and it is essential that dose adjustments are made with the same timing relative to the dose. Samples taken less than 12 hours after the dose will have inappropriately high results due to incomplete distribution into peripheral tissues. Adjustment of patient doses using such values may result in lower than optimum dose for that particular patient and possible earlier treatment failure.
Advice
Interpretation of results for Lithium. Before interpreting a result check the specimen timing was correct Ranges were originally derived for treatment of acute mania and then adopted for maintainance. A variety of therapeutic ranges have been suggested because the effectiveness is better at higher concentrations (longer 'survival' without relapse) but does not correlate very well with concentration. Similarly Side effects are more troublesome at high concentrations so the upper limit has gradually decreased with time as the balance is re-
Author Title Document No.
Dr Richard Stott Lithium PD-UserHbk-019 ver1.0
Page 1 of 3 14/05/2007
asessed. In 1985 the National Institutes of Mental Health consensus development conference reccomended 0.6 - 0.8 mmol/L but we use the range which Baastrup (1980) found to be effective in 80% of patients. Therapeutic range - 0.5 - 1.0 mmol/L An individual patient's levels should probably be decided according to severity of side effects rather than strict concentration values. Apparently toxic results are commonly due to sampling too early after an increase in dose or too soon after the dose. Common side effects Tremor Weight gain Polyuria Fatigue Polydipsia Aggravated Psoriasis Nausea or Acne Diarrhoea Hypothyroidism
Recommended actions Review indications for Lithium Therapy Check 12 hour level, U & Es, TFTs Adjust dose accordingly Omit Lithium if diarrhoea persists
Before interpreting a result check the specimen timing was correct. Causes, Symptoms and Treatment in the event of OVERDOSE. Toxic effects are commonly caused by chronic over dosage as a consequence of renal excretion alterations. Toxic symptoms relate loosely to Li concentration as there appears to be an effect of duration of elevation in Li level on severity. Creatinine clearance and other renal function indicators are usually abnormal in chronic overdose. Deliberate self poisoning is relatively uncommon and toxicity is normally milder than chronic overdose with similar Li levels. Clinical Grade Typical Li mmol/L Symptoms. O 0.4 - 1.3 No symptoms / Anxiety. I 1.5 - 2.5 Nausea, vomiting, diarrheoa, tremors, muscle weakness, agitation, lethargy, blurred vision, confusion, fasiculations, myoclonic twitches, hyperreflexia, ataxia, blurred vision. II 2.5 - 3.5 Stupor, rigidity, Parkinsonism, hypotension. III >3.5 Convulsions, coma, circulatory collapse. Individual patients may display symptoms which do not correlate with the tabulated symptoms particularly in acute overdose. One acute overdose patient is reported with Li results of 2.7 mmol/L with no symptoms whereas another patient died after presenting with a level of 1.2 mmol/L after having had toxic symptoms for 8 days.
Advice
Signs of Toxicity Apathy Ataxia Muscle Weakness Nystagmus Restlessness Coarse Tremor Confusion Fits Vomiting Renal Failure Diarrhoea Coma
Action Obtain urgent level (must be absolute level) Check U & Es urgently IV fluids Referral for general medical care Renal specialist unit if renal failure develops Discontinue Lithium immediately.
Lithium should be stopped immediately if the above toxic symptoms are experienced. It may be necessary to admit the patient for medical observation if lithium toxicity is suspected. If hyper-reflexia and hyper-extension of limbs, convulsions, toxic psychosis, syncope oliguria, circulatory failure or coma occur, then this is an emergency and the patient should be admitted urgently for further medical care.
Treatment of Lithium OVERDOSE.
Author Title Document No.
Dr Richard Stott Lithium PD-UserHbk-019 ver1.0
Page 2 of 3 14/05/2007
1. IV Rehydration is often recommended because of dehydration in chronic intoxication. This will increase Li excretion if the initial problem was due to hypovolaemia and low GFR. This does not increase fractional Li excretion and may take a long time to effectively clear accumulated Li. This is only suitable for mild intoxication and response should be monitored using serial Li measurements. More aggressive treatment is required if the level will not fall below 0.6 mmol/L within 36 hours. 2. Lithium is effectively cleared by dialysis (about 5 fold greater clearance than by rehydration alone) but Li levels will rebound after cessation of dialysis due to the slow re-equilibration of tissue Li into circulation. Measurement of Li 6 hours post cessation is recommended to assess the need for repeat dialysis. Indications for dialysis include: • Presence of Grade III symptoms. • Li levels exceeding 4.0 mmol/L. • Chronic intoxication with levels exceeding 2.5 mmol/L and serious cardiac / CNS manifestations. • Serial levels predict that Li will not be < 0.6 mmol/L within 36 Hrs despite IV rehydration. References
Advice
1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Lithium intoxication. Hansen & Amdisen. Q.J. Med. 47, 123 (1978) 4. Lithium intoxication: Clinical course and therapeutic considerations. Gadallah et al. Mineral Electrolyte Metab. 14: 146 - 149. (1988) 5. Self-poisoning and therapeutic intoxication with lithium. Dyson et al. Human Toxicol 6: 325 - 329. (1987) 6. Lithium pp. 1042 - 1046 in Medical Toxicology Diagnosis and Treatment of human poisoning. (Ellenhorn and Barceloux Eds. Elsevier, New York) ( 1988) 7. Lithium PP. 427 - 431 in Goldfrank's Toxicological Emergencies. Appleton & Lange, Norwalk, Ct) (1990) 8. Lithium. pp. 656 - 665 in Clinnical Management of Poisoning & Drug Overdose. ( Haddad & Winchester. Eds. Saunders Co, Philadelphia) (1990) 9. Massive overdoses with sustained-release lithium carbonate preparations: Pharmacokinetic model based on two case studies. Griedberg et al. Clin. Chem. 37: 1205 - 1209. (1991) 10. Lithium in the prophylactic treatment of recurrent affective disorders. Baastrup. In Handbook of Lithium therapy. (Johnson Ed. ) Park Press. Baltimore (1980).
Author Title Document No.
Dr Richard Stott Lithium PD-UserHbk-019 ver1.0
Page 3 of 3 14/05/2007
Directorate of Pathology Timing of samples and interpretation for measurement of Phenobarbitone This page is divided into sections as follows:â&#x20AC;˘ Timing of measurements after starting therapy or a dose change. â&#x20AC;˘ Timing of measurements relative to taking the dose. â&#x20AC;˘ Interpretation of results. You may also want to review the Pharmacy formulary site page about anticonvulsants and the page about Importance of specimen timing in therapeutic drug monitoring. KEY FACTS - Phenobarbitone Sample timing - Typical dose 60 - 180 mg taken once per day. The dose frequency is less than the elimination half life therefore there is a considerable delay between commencing treatment or changing dose and achieving steady state conditions. For routine dose changes or initiation of treatment with maintenance doses allow 21 days after initiation of treatment or dose change. A single loading dose of 3 to 4 times the maintenance dose may be used to reach equilibrium concentrations rapidly. Monitoring can begin immediately before the second maintenance dose. Samples should be taken immediately before taking the dose. Therapeutic range - 80 - 160 umol/L Expect severe toxicity about 450 umol/L. Phenobarbitone may be effective in preventing siesures at concentrations well below the therapeutic range in some patients (Particularly after long term treatment). Sub therapeutic levels are not necessarily an indication for a dose increase or withdrawing the drug in patients with good control. Bioavailability of oral dose - Peak concentration 50 - 100 hours post dose. Metabolism - Phenobarbitone is metabolised by the liver to inactive metabolites. Half life of elimination ranges from 50 to 120 Hrs in adults and 40 - 70 Hrs in children. This long half life necessitates long waiting times between commencing treatment or changes in dose & monitoring. Caution Phenobarbitine levels may increase sharply if Valproate is added to the drug regimen. Phenobarbitone (or Primidone) dose must be reduced accordingly and monitoring of valproate & phenobarbitone may be required. Distribution - Volume of distribution is 0.7 - 1.0 L/Kg Timing of Phenobarbitone measurements after starting treatment or a dose change. Elimination half-life is variable (At least 40 Hours) and can be very long in some patients (up to 5 days), therefore the delay required between dose adjustments and monitoring can exceed three weeks. Monitoring prior to this may be acceptable in many patients but results should be interpreted cautiously as further increase may occurr.
Advice
Interpretation of results. Before interpreting a result according to the therapeutic range, check the specimen timing was correct Therapeutic range - 80 - 160 umol/L CAUTION Levels correlate poorly with side effects. New patients may show marked drowsiness at levels as low as 20 umol/L whereas long term patients may tolerate up to 260 umol/L with no ill effects. Expect severe toxicity about 450 umol/L. Results must be interpreted relative to clinical symptom rather than levels alone. Phenobarbitone may be effective in preventing seizures at concentrations well below the therapeutic range in some patients (Particularly after long term treatment). Sub therapeutic levels are not necessarily an indication for a dose increase or withdrawal of the drug in patients with good control.
Author Title Document No.
Peter J Taylor Phenobarbitone
Page 1 of 2 22/03/2007
Timing of Phenobarbitone measurements relative to taking the dose. Remember: Drug concentrations are not stable at any time after the dose unless the required time has elapsed since commencing treatment or the last dose change. The concentration of Phenobarbitone is most stable and correlates with therapeutic effects close to the time of taking the next dose. Values measured at this time have been used to derive the therapeutic range and this timing should also be used in taking samples to direct changes in dose. Specimens taken substantially before this timing will yield inappropriately high results due to incomplete distribution into peripheral tissues and may result in selection of an inappropriately low dose. References:
Advice
1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Individualizing Drug Therapy. Gross, Townsend, Frank INC, New York. Library of Congress No 8182052
Author Title Document No.
Peter J Taylor Phenobarbitone
Page 2 of 2 22/03/2007
Directorate of Pathology Timing of samples and interpretation for measurement of PHENYTOIN. This page is divided into sections as follows:Common indications for measurement. Timing of measurements after start of treatment. Timing of measurements after a dose change. Timing of measurements relative to taking the dose. Interpretation of results. Symptoms, Actions and future measurements in the event of OVERDOSE. You may also want to review the Pharmacy formulary site page about anticonvulsants and the page about Importance of specimen timing in therapeutic drug monitoring. KEY FACTS - PHENYTOIN Sample timing - Trough level (Immediately before next dose) at least 11 days after initiation of treatment with 'maintenance' dose. Alternatively 2 - 4 hours post loading dose. ( Requires 2 - 4 weeks to reach appropriate induction therefore levels will fall despite initial demonstration of adequate dose) . After initial induction, further monitoring must be at least 4 weeks post dose change. Therapeutic range Total phenytoin 40 - 80 micro mol/L (Single drug) For more details see Interpretation. (Free phenytoin 3.5 - 7.5 micro mol/L) Toxic effects are likely above 80 micro mol/L including 'Paradoxical' seizures. Some patients require high levels to achieve adequate control. Bioavailability of oral dose Typically 90% but may vary significantly with formulation. Take care when changing formulation as large concentration changes may occur with apparently constant dose. Metabolism - Hepatic oxidation. This system is saturable at drug concentrations within the target range. Dose and blood levels are not linearly related. Phenytoin (and other drugs) also induces the enzymes so metabolism depends on drug history. Protein binding - about 90% protein bound but displaced by other drugs (e.g. Valproate) leading to decrease in total phenytoin in blood but increased 'Free' phenytoin. Also lowered in pregnancy, renal disease, hepatic disease and in Neonates. In these situations, measurement of 'Free' phenytoin may be indicated. Elimination - Hepatic metabolism and Excretion via kidneys. Saturation of hepatic metabolism makes elimination dependent on concentration and highly variable between individuals. Effective half lives vary with age and drug therapy history. Typically values • 75 Hrs in pre-term neonate. 21 Hrs in term neonate. • 7.5 Hrs in infants / children. • 9 - 22 Hrs for adults taking single dose. • 20 - 40 Hrs for adults on chronic therapy. • May be up to 100 Hrs on high doses. Deterioration in renal function may lead to increased levels of metabolite which is measured by some assays and give misleading results. Common indications for measurement of PHENYTOIN.
Advice
Timing of PHENYTION measurements after a dose change. Treatment is usually commenced using the 'Maintenance dose' of Phenytoin. In 'Status Epilepticus', rapid onset of symptom control is essential and there will be an initial 'loading dose' usually given as an IV infusion over several hours. This achieves the steady state condition very rapidly. The first 'Maintenance dose' is given the appropriate time later and monitoring can commence after this dose. Author Title Document No.
Dr Richard Stott Phenytoin PD-UserHbk-020 ver1.0
Page 1 of 2 22/03/2007
In treatment with 'Maintenance' doses (Starting at 3 - 4 mg/Kg (Typically 150 - 300 micrograms) either as a once a day dose or divided into two), the elimination half-life of Phenytoin regulates the accumulation between doses. Between three and five half lives being required before the difference between current and 'steady state' concentrations is less than the assay imprecision (Typically 5 - 10% CV). In normal individuals the half life is between 20 and 40 hours and therefore a period of 11 days should be allowed before checking the concentrations achieved. The dose is then gradually increased to achieve adequate relief from symptoms (Typical final doses about 300 mg per day). Timing of PHENYTOIN measurements relative to taking the dose. Trough levels (Just before the next dose) are the most stable. These are used in defining the target range. Interpretation of results for PHENYTION. Before interpreting a result check the specimen timing was correct Target range depends on the indication for phenytoin administration and the other drugs co-administered. The range given in the laboratory computer relates to treatment of Epilepsy using phenytoin alone. See later in this section for other indications and multi-drug therapy. Single drug therapy for epilepsy or Trigeminal neuralgia • Therapeutic range - Total phenytoin 40 - 80 micro mol/L (Single drug) • Toxic effects are likely above 80 micro mol/L including 'Paradoxical' seizures. • Some patients may benefit from carefully increasing the dose to give concentrations above 2.6 nmol/L if no adverse effects become evident. Notes 1. The dose and plasma concentration are not linearly related in a given patient and small dose adjustments can lead to disproportionately large increases in levels. Monitoring is required with each change in dose. 2. Addition, Cessation or dose adjustment of other drugs will require alterations in the dose of phenytoin and necessitates monitoring phenytoin and all interacting anticonvulsants to adjust the doses appropriately. (Remember that any induction / de-induction of metabolism requires up to 4 weeks to complete, Do not adjust the dose using results from drug monitoring before this is completed. Multi-drug therapy for epilepsy. 1. Due to drug interactions the dose of phenytoin may require alteration whenever an interacting drug is started, stopped or the dose is changed. 2. Take great care in deciding the timing of the samples, all interacting drugs should have reached steady state before monitoring is commenced. This requires 3 to 5 times the half-life of the slowest drug to reach steady state. In addition the 4 weeks delay for changes in metabolic induction must be remembered. Free phenytoin 3.5 - 7.5 micro mol/L Causes, Symptoms and Treatment in the event of OVERDOSE. Causes of Phenytoin OVERDOSE. Diagnosis should depend on a careful clinical examination and should not be entirely based on Phenytoin measurement as toxic symptoms may occur within the therapeutic range and a few patients may require apparently 'Toxic' concentrations for optimal symptom relief. Common causes of toxicity include :• Too large a dose increase. In many individuals a small dose increase can lead to disproportionate concentration increases with 'toxic' symptoms becoming evident. Changes in dose of / addition of drugs which interact due to common metabolic pathway or protein binding.
Advice
References 1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Individualizing Drug Therapy. Gross, Townsend, Frank INC, New York. Library of Congress No 8182052
Author Title Document No.
Dr Richard Stott Phenytoin PD-UserHbk-020 ver1.0
Page 2 of 2 22/03/2007
Directorate of Pathology Timing of samples and interpretation for measurement of Valproate. This page is divided into sections as follows:â&#x20AC;˘ Timing of measurements after starting therapy or a dose change. â&#x20AC;˘ Timing of measurements relative to taking the dose. â&#x20AC;˘ Interpretation of results. You may also want to review the Pharmacy formulary site page about anticonvulsants and the page about Importance of specimen timing in therapeutic drug monitoring to see why the kinetic variability of Valproate makes therapeutic monitoring impractical. KEY FACTS - Valproate Monitoring of Valproate for therapeutic adjustment is contraindicated Valproate levels are not useful in adjusting therapeutic doses as it is impossible to derive an adequately defined therapeutic range for use with a single measured level. The only indication is in therapeutic failure where elevated results indicate that an alternative anticonvulsant should be used. Sample timing - Immediately before taking the dose, at least 3 days after initiation of treatment or dose change. 15 days when co-administered with Lamotrigine. Therapeutic range - 350 - 700 umol/L This range is not well established due to poor correlation between levels and effect. Toxic effects do not correlate with concentration. Some patients are well controlled at levels below 350, others require levels far in excess of 700. Bioavailability of oral dose - Peak concentration about 2 Hrs post dose. Metabolism - Hepatic oxidation & conjugation to yield active metabolites with long half lives. Onset of therapeutic effects is delayed compared to plasma level reaching 'therapeutic' levels & persists after complete clearance of parent drug. Valproate coadministration extends the elimination half time for Lamotrigine due to competition for metabolism. Distribution - Volume of distribution is small (0.1 - 0.4 l/Kg). Protein binding is concentration dependent leading to non-linear relationship between dose & free drug concentration. Valproate is displaced from binding by free fatty acids so binding (& elimination kinetics) vary between fasted & fed states. Valproate levels may vary as much as 100% over the dose interval. Levels are not reproducible even the same stage of successive twice daily doses. Elimination - Half life ranges from 7 - 16 Hrs. Both hepatic oxidation & renal excretion are highly variable and are effected by other anticonvulsants (notably Phenytoin & Phenobarbitone). Timing of Valproate measurements after starting treatment or a dose change. In large groups of patients the apparent half life of elimination is between 7 and 16 hours therefore leaving 3 days after a dose change should lead to steady state concentrations of the parent drug. The validity of this half life is minimal because most of the activity derives from active metabolites and therapeutic effects require considerably longer than this to establish. Similarly therapeutic effects persist well after the parent drug is eliminated from circulation. Timing of Valproate measurements relative to taking the dose. Remember: Valproate concentrations are not stable at any time after the dose due to the effects of diurnal variation, Fed/Fasted state and interactions with other anticonvulsants. Valproate levels may vary as much as 100% over a single dose interval and are not reproducible even the same stage of successive twice daily doses. Trough levels (Just before the dose) are traditionally used for clinical convenience and the attempts ar deriving therapeutic ranges all use this timing.
Advice
Interpretation of results for Valproate. Before interpreting a result check the specimen timing was correct Therapeutic range - 350 - 700 umol/L
Author Title Document No.
Dr Richard Stott Valproate PD-UserHbk-021 ver1.0
Page 1 of 2 22/03/2007
This range is not well established due to poor correlation between levels and effect. Toxic effects do not correlate with concentration. Some patients are well controlled at levels below 350 others require levels far in excess of 700. In patients with poor control, the presence of a level in excess of 1000 umol/L indicates that an alternative anticonvulsant should be substituted. References:
Advice
1. British National Formulary (March 1995) 2. Therapeutic Drug Monitoring. (Hallworth and Capps). ACB Venture publications, London. ISBN 0 902429 05 1 3. Individualizing Drug Therapy. Gross, Townsend, Frank INC, New York. Library of Congress No 8182052
Author Title Document No.
Dr Richard Stott Valproate PD-UserHbk-021 ver1.0
Page 2 of 2 22/03/2007
Directorate of Pathology Timing of samples for measurement of Therapeutic Drugs. Why is correct timing of the sample important ? For a drug measurement to be of any use at all it must be answering a specific clinical question, this often implied rather than consciously asked. Common questions include 1. Is the dose of drug sufficient to have a therapeutic effect? 2. Is the dose of drug excessive and causing unwanted effects? 3. Is there some interaction with other drugs causing unusual behavior of the drug? 4. Has a change in the patient's condition altered drug handling and changed the therapeutic effect? 5. Is the patient taking the drug at all?
Advice
In all but the last case the answer depends to some extent on our understanding of the relationship between dose administered, blood concentrations achieved at a certain time after the dose and the therapeutic actions of the drug. The blood concentration of all drugs varies with the time after each individual dose, this is dependent on two or three processes depending on the route of administration. The concentration initially rises as drug arrives in circulation then reaches a plateau and subsequently declines until the drug is entirely removed from circulation or another dose is given. Where several doses are given the concentrations achieved after each dose will be influenced by the drug remaining from prior doses and the drug will tend to accumulate until a steady state is reached after which each new dose will behave essentially the same. Depending on the route of administration, either two or three processes control the rates of change of drug concentration. Each of these processes acts simultaneously on the circulating drug although a single process is usually the dominant determinant of concentration at any time after the dose. 1. Drugs given orally have an initial absorption phase during which the dose (or a fraction of the dose) is absorbed from the intestines. The timing and extent of absorption depends on the site of absorption of a particular drug, rate of passage through the gut and possibly the nature and relative timing of recent meals. These influences may result in large differences in handling of a drug between individuals and between days within the same individual. Oral doses are absorbed and immediately presented to the liver for possible metabolism (First pass metabolism) before reaching the systemic circulation. The precise behavior of drugs given by the oral route may be affected by coexisting medical conditions including diseases of the GI tract, Liver and Pancreas as well as the administration of other drugs. 2. Drugs given as a timed IV infusion have a highly predictable absorption phase and are immediately available in circulation without being presented to the liver. Therefore the distribution of metabolites in circulation (and hence therapeutic effects) may be very different from those obtained for the same drug given orally. 3. Drugs given as an IV bolus do not have an absorption phase and are immediately available in circulation. 4. Drugs given as an IM bolus have an absorption phase which depends on the rate of transport away from the immediate site of administration which may vary considerably according to site and local blood flow. This route also avoids first pass metabolism of the drug. Once in circulation the drug is available for distribution into the various tissues. The extent of distribution into particular tissues depends on several factors including the extent of protein binding, lipid solubility and active uptake by particular tissues (eg. Hepatocytes). The extent and rate of distribution of a drug in an individual may be affected by the proportion of body mass composed of adipose tissue (Generally a higher proportion of total body weight in females than males and also altered by physical training and obesity.). Disease processes and other drugs may affect the distribution phase by altering protein binding or active transport processes. This process is also important in delivering active drug molecules to the sites of action which are rarely directly accessible by molecules in the blood. The same processes act in reverse direction during periods of declining drug concentration although the transport processes and rate of movement may be different. Elimination of the drug from circulation depends on the presentation of drug molecules to sites of metabolic alteration (Mainly hepatic but other sites may be important in specific drugs) and excretion (Mainly renal via urine and hepatic via bile but other routes are significant in some drugs e.g. sweat, milk etc.) Although some drugs are metabolized by processes which have fixed maximum rates or are not concentration dependant, usually each process contributes or removes drug molecules according to first order kinetics (rate of removal or delivery is proportional to concentration). This results in an exponential increase in blood concentration after an oral dose which is followed by an exponential fall. This is usually not due to a single Author Title Document No.
Dr Richard Stott Timing of Therapeutic monitoring PD-UserHbk-022 ver1.0
Page 1 of 6 20/04/2007
process but the differing routes of distribution and elimination can be thought of as a sequence of exponential processes. At any time after the dose there is usually a single dominant process and the decline can be represented by a single half life of accumulation immediately after the dose and a single half life of decline. This is often termed the 'elimination' half life although it may not be entirely due to a single excretion or metabolic process.
Concentration of drug after a single dose
Concentration 16
12
Elimination phase Half life = 6
8
Absorption phase Half life = 6
4
0
0
10
20
30 40 Time after dose
50
60
When multiple doses are given more frequently than about 5 elimination half lives apart, clearance is not completed before the next dose is taken. Most drugs which require monitoring have an elimination half-life similar to or shorter than the dosing interval and so drug metabolism eventually reaches steady state when the concentrations are consistent at any particular time after the dose.
Concentration of drug when multiple doses are given Concentration 16
12 Dose
Final trough value = 12
Dose
8
Difference between trough level and final trough concentration decreases by half for each elimination half life since first dose.
Dose 4
Dose
Elimination half life = 10 Dosing interval = 12
Advice
0
0
10
20
30
40
50
60
Time after first dose At any fixed time after the dose the drug levels behave as if they increase with a doubling time identical to the elimination half life, therefore results become stable after between 3 and 5 elimination half lives. After this time any further change in concentration is less than the variability in results for replicate measurements (Typically 5 - 10 % Coefficient of variation between replicates of the same sample). Why do we only measure certain drugs. Author Title Document No.
Dr Richard Stott Timing of Therapeutic monitoring PD-UserHbk-022 ver1.0
Page 2 of 6 20/04/2007
For many drugs there is a wide margin of error between the dose at which the effects are 'Therapeutic' and those at which 'Toxic' effects predominate or become clinically obvious due to unmistakable symptoms. Other drugs have a narrow range of therapeutic concentrations but the toxic effects are clinically evident and the relationship between the dose taken and its effects is consistent. Drugs with these characteristics can be given at a standard initial dose and the dose adjusted by progressively according to clinical response. These drugs do not require concentration monitoring to ensure safety or adequate therapeutic action unless there is some form of interaction between drugs. Drugs which have a narrow therapeutic range in combination with one or more of the following properties will require concentration monitoring to achieve safe levels. • Large intra-individual variability in metabolic handling. • Non-linear dose/response effects such as saturable metabolism. • Poorly predictable effects of concurrent illness e.g. renal function, jaundice, electrolyte abnormalities. • Interactions with other drugs which are co-administered. • Absence of clinical signs of sub therapeutic or toxic concentrations ( or no difference between the signs). The degree of variability may be sufficient to make an otherwise safe drug unpredictable under certain conditions and concentration monitoring may be useful. As an example of the variability in individual handling of a drug the following graph shows the concentrations achieved after a standard dose of phenytoin.
Concentration of Phenytoin in 200 individuals taking 300 mg per day % of patients 15 Target range 10 - 20 mg/L 10
5
0
Advice
0 10 Plasma Phenytoin (mg/L)
20
30
40
50
Requirements for therapeutic drug measurements to be clinically useful. There are several basic requirements which must be met before therapeutic monitoring can be usefully undertaken, these mainly relate to the practicalities of obtaining a result which can be interpreted, these questions usually require the study of large numbers of individuals to determine the suitability for monitoring. 1. Timing. There must be some time after the dose where the intra-individual variability, disease effects and drug interactions allow a relatively steady drug concentration to be achieved. This results in greater stability for the therapeutic ranges. This is often the 'Trough level' just before the next dose or a 'Peak level' some time after the dose where the absorption and distribution phases are complete but extensive elimination has not yet occurred. In situations where there are effects of other drugs given at the same time, the implications for sampling times should be considered and sample timing modified if necessary. 2. Sample. Blood (or other sample) concentration must correlate with clinical effect. For the concentration to be useful it must be possible to define a target range which is associated with therapeutic effects. This is only possible if the blood concentration closely correlates with that at the active site of the drug. For example the total concentration of a drug which is extensively protein bound in serum may be affected by changes in protein content and fail to indicate the available amount at the receptor (In this case the free drug may be a better measurement). Similarly the concentration within the blood may be unrepresentative of that in a particular body compartment e.g. CSF and therefore may not indicate
Author Title Document No.
Dr Richard Stott Timing of Therapeutic monitoring PD-UserHbk-022 ver1.0
Page 3 of 6 20/04/2007
therapeutic effect. Failure to achieve this correlation makes it impossible to accurately define a target range for therapeutic effect. 3. Assay. There must be a readily available assay which measures the parent drug and / or appropriate metabolites. The identity of the assay will determine the target range to be used. It is particularly important to use the appropriate ranges where there are multiple metabolites as certain molecules may be detected by one method but not another. The characteristics of the assay may also determine how long it takes to return results and whether monitoring is available daily, weekly or only by prior arrangement. This may alter the situations in which a drug measurement is useful. For example, determining the next dose of a drug to be given is practical using an automated immunoassay which is available 24 hours a day and returns results within 30 minutes but not with a manual HPLC method which takes the whole day to get a result. 4. Interpretive information There must be a well defined target range determined for a large number of individuals treated with the drug of interest and determined using the assay method in the laboratory (Or one which measures the same metabolites). Where there are confounding factors such as effects of other drugs, this should be investigated and alternative target ranges determined. Timing of measurements after start of treatment. From the previous section it should be apparent that drug handling but the individual patient should be at or close to the steady state condition before monitoring will produce a result which can be usefully interpreted. The difference between the current and steady state drug concentration halves for each elimination half life which passes since the drug was started. For the results to be interpretable the likely error in determining the drug concentration should be of similar magnitude or greater than any error due to failure to achieve steady state. Therefore monitoring of most drugs should not be started until at least 3 half lives after starting the drug administration. Taking the sample during a dose cycle prior to steady state will usually result in a falsely low result as the drug has not yet fully accumulated in the patient. For some drugs, however, the result will be falsely high as the drug is not yet fully distributed into the tissues. Either of these circumstances would lead to an inappropriate decision that the patient is likely to be adequately treated or that a dose change is required. The only exception to this general timing rule is for drugs where a loading dose is given. In this situation a large initial dose is given to achieve therapeutic effects rapidly. This dose is calculated so that it will distribute through the tissues to achieve the same concentrations as would result at steady state, thus achieving therapeutic concentrations several elimination half lives earlier than with multiple 'Maintenance doses' of the drug. The first 'Maintenance dose' is then given after an equilibration time (Which may be longer than the normal time between maintenance doses). In this situation it is valid to check the concentration is 'Therapeutic' prior to giving the first maintenance dose. The actual timing of the first dose cycle available for monitoring a particular drug is given in the timing details available from that particular analysis page. Timing of measurements after a dose change. The rationale in determining when to monitor after a dose change is identical to that for initiation of therapy except that there is already some drug accumulated in the system. The difference between the current and steady state drug concentration halves for each elimination half life which passes since the dose was changed. For the results to be interpretable the likely error in determining the drug concentration should be of similar magnitude or greater than any error due to failure to achieve steady state. Therefore monitoring of most drugs should not be started until at least 3 half lives. Taking the sample during a dose cycle prior to re-establishing steady state will usually result in a falsely low result which could lead to an inappropriate decision that a further dose change is required. The actual timing for monitoring a particular drug is given in the timing details available from that particular analysis page.
Advice
Timing of measurements relative to taking the dose. From the previous section it should be apparent that the drug concentration should be at a relatively constant level in the particular patient before monitoring and that the timing should be the same as that used to produce the 'Target range' data. Very large errors can occur if the sample timing is not within the optimum period as the concentration may be changing rapidly. For example a sample taken two hours late may fall on a steep exponential fall in concentration rather than the plateau and could produce a low concentration leading to an inappropriate decision to increase the dose. Similarly, a sample taken two hours early may fall in a period of rapid absorption with little distribution and the actual timing of samples relative to the dose is given in the timing details available from the analysis page for each drug.
Author Title Document No.
Dr Richard Stott Timing of Therapeutic monitoring PD-UserHbk-022 ver1.0
Page 4 of 6 20/04/2007
Effects of sampling at an appropriate time relative to the dose Concentration Sample with apparently 'Toxic' result
Target range
Sample with apparently 'sub-therapeutic' result
Sampling interval 17 - 33 time units 0
10
20
30
40
50
60
Time after dose Information required on the request form for drug measurements. Certain information must be accurately recorded to enable the clinician to be able to interpret the results and the laboratory to attach appropriate interpretative ranges. The absolute minimum information on the request form is as follows:• Date of last change in drug dose. • Date and time of last dose of drug. • Date and time sample was taken (This must be within the specified time range after the last dose. About 10% of samples for some determinations are taken too early!) • Dose of drug and frequency of administration. • Name of drug administered (Especially where there are several formulations e.g. fast acting, slow release etc.) • Names of other drugs which are co-administered (These may alter the interpretation of a result if the drugs interfere in the metabolism of the drug being measured). • Which drug is to be measured (We often get a long list of drugs in the clinical details box and no clear request for measurement, your request may be ignored!). • Reason for the request plus relevant clinical details. Interpretation of results. Interpretation of the results of therapeutic drug monitoring requires a combination of judgement about the patient's clinical state, the analytical result and the 'Target range'. It must be remembered that the 'Therapeutic range ' is only a guide, individual patients may have differences in drug distribution or transport which alter drug availability at the receptor. As a consequence of these differences, some patients achieve adequate relief of symptoms before the results are in the range (And will have 'Toxic' symptoms within the target range), in these individuals levels below the 'Therapeutic range' do not indicate that a dose increase is required. Other patients may require cautious increase in dose producing results in the apparently 'Toxic' region before adequate symptom control is achieved. Before making a decision based on the results, it is essential to consider the following data to ensure that the appropriate sample timing limitations are complied with and that the appropriate target range is being used:
Advice
• • • • •
Current dose of drug, formulation (e.g. Slow release tablet, or liquid) and frequency of administration. Drugs which are co-administered (These may alter the interpretation of a result if the drugs interfere in the metabolism of the drug being measured). Date of last change in drug dose (Check relative sample timing !). Date and time of last dose of drug.(Check relative sample timing !). Date and time sample was taken
Author Title Document No.
Dr Richard Stott Timing of Therapeutic monitoring PD-UserHbk-022 ver1.0
Page 5 of 6 20/04/2007
Therapeutic ranges and details of sample timing restrictions are given in the timing details available from the analysis page for each drug. The ranges given on the laboratory computer system and the main page for each drug are appropriate to single drug treatment using the conventional formulation and normal sample timings. The specimen timing page may have additional information about target ranges and specimen timing for other formulations and multi drug therapy. Take care to check that you are using the most appropriate range for the individual patient. Drug Toxicity. Most 'Toxic' effects are related to drug concentration in the same way as therapeutic effects and have a threshold at which they become noticeable, The site of action for toxic effects may be different from that for therapeutic and therefore there may be a completely different set of distribution and elimination processes, however for most drugs the blood levels are as good at predicting toxicity as therapeutic effects. In some cases the reason for monitoring the drug is related only to it's potential toxicity as the levels achieved are not correlated well with therapeutic outcome (For example many antibiotics are potentially toxic but are used at blood levels far in excess of the minimum inhibitory concentration). The majority of drugs are metabolized at a rate which is concentration dependent therefore concentrations change gradually. In these drugs the final concentration is linearly related to the dose and quite large dose increases can be tolerated. The onset of toxicity due to an increased dose will be gradual as will toxic effects precipitated by a metabolic change such as renal failure or hypokalaemia. In mild overdose, symptoms are most likely to occur during the period of peak drug concentration. As the degree of excess increases, the concentration becomes 'Toxic' earlier after the dose and remains high for a longer time, additional symptoms may also occur as the peak concentration increases.
Advice
Drugs with saturatable metabolism do not show a linear relationship between dose and concentration. Drug concentrations can increase several fold after a small dose increase if it causes the delivered amount of drug to exceed the metabolic capacity. An increase of several fold may be caused by a small fractional dose increase. These drugs (e.g. Phenytoin, Carbamazepine ) may cause continual, severe symptoms a short time after the first inappropriately high dose. Similarly the symptoms may persist for a long period after stopping the drug while the excess is cleared.
Author Title Document No.
Dr Richard Stott Timing of Therapeutic monitoring PD-UserHbk-022 ver1.0
Page 6 of 6 20/04/2007
Code of Practice for Visitors to Pathology (HS-COM-002) Due to the nature of the work involved in diagnostic laboratories and the hazardous substances/ agents in use, the following regulations must be adhered to at all times during your visit to Pathology. Visitors must be accompanied at all times by an experienced member of staff. Please comply with any instructions issued by your host during your time in Pathology. Wear protective clothing if it is provided and find out where you should discard it after use.
Pathology services encompass the Departments of Clinical Biochemistry, Haematology, Histopathology, Cytology, Morbid Anatomy, Microbiology, Virology and Immunology.
Safety information for laboratory visitors
Pathology Laboratories are situated on the Doncaster Royal Infirmary and Bassetlaw District General Hospital sites. Phlebotomy services are also available on the Montagu site.
Welcome We would like to welcome you to the Directorate of Pathology and wish your visit to be safe and successful. On arrival you must ensure that you have signed the visitor’s book to record your presence in one of the buildings. You will be issued with a temporary visitor’s badge whilst on the premises. Please also ensure that you sign out when you leave and return the visitor’s badge to the office. Your host will be able to guide you through this procedure. Whilst waiting we ask you to carefully read the information in this leaflet. Its purpose is to ensure that the high standards of safety are extended to you and that your safety is not compromised during your visit.
OPENING HOURS The laboratories are generally open from 0900 - 1700 Monday to Friday. Please see Laboratory Handbook department sections for precise opening hours.
Cover all open cuts, abrasions etc. using waterproof dressings. Do NOT eat, drink, smoke, apply cosmetics or chew gum during your visit and avoid hand to mouth contact in laboratory areas. Do NOT touch working areas or equipment unless you are told it is safe to do so and ensure long hair is tied back.
N
SM KING
Doncaster and Bassetlaw Hospitals NHS Foundation Trust operates a no smoking policy on all of its premises
Before leaving the laboratory wash your hands thoroughly. (Always ensure you wash your hands before meal breaks).
Advice
On hearing the fire alarm, you must stay with your host who will escort you to safety.
SAMPLES - HEALTH & SAFETY Never eat, drink or smoke when transporting specimens and wash your hands frequently. Carry all specimens in the approved specimen container - not in your pockets. If there is a specimen breakage and spillage, isolate the area to prevent access. If you have an accident involving contamination with a specimen, contact a senior member of staff in the clinical or laboratory area. The tissue fixative for routine histology specimens is 10% formalin (a 4% solution of formaldehyde). This is a hazardous chemical, which should be handled with care. The laboratory can advise on storage handling and substance monitoring. Please refer to Trust Standard Precautions policy PAT/IC19 available on the website.
Uncontrolled copy for temporary use only
Any accidents or incidents involving visitors must be reported immediately to the accompanying member off staff and subsequently to the Departmental Safety Officer who will complete an accident form if necessary.
Site Safety The Directorate of Pathology is committed to fulfilling its legal requirements under the Health and Safety at Work Act (1974) and all other pertinent regulations. Therefore, you have a legal requirement to follow any signs or instructions. You must not risk the safety and welfare of any person on the site including yourself. If you see any process or practice which you consider unsafe please report it to your host. In order to minimise any risk of infection you must not eat, including gum or sweets, drink or apply cosmetics except in designated areas. Your host will clarify any safety matter about which you may be unclear. In the unlikely event of an accident, or something that might contribute towards an accident, please inform your host.
www.dbh.nhs.uk
Bassetlaw
Doncaster Level 1 CORRIDOR
WC COAGULATION
RECEPTION
BLOOD BANK WAITING ROOM
BLOOD BANK HAEMATOLOGY
RECEPTION
STORE
HAEMATOLOGY
WC
WC PHLEBOTOMY
OFFICE
COAGULATION STORE
OFFICE
OFFICE
ON CALL ROOM
OFFICE OFFICE
STAFF ROOM
SEMINAR ROOM
WC
STORE
WC
STORE POST ROOM OFFICE
OFFICE
ON CALL ROOM
OFFICE
OFFICE
OFFICE QUADRANGLE
OFFICE
OFFICE OFFICE
WC COMPUTER ROOM
OFFICE
STAFF ROOM
OFFICE
CLINICAL CHEMISTRY
OFFICE
OFFICE
LIFT OFFICE
OFFICE STORE
OFFICE
OFFICE CLINICAL CHEMISTRY
VIROLOGY MICROBIOLOGY
Fire Safety
OFFICE
WC
BOOKING IN AREA
POST ROOM
OFFICE
AUTO CLAVES
CLINICAL CHEMISTRY
The Trust accepts no responsibility for any loss or damage to personal property on the Trust site. If you suffer any loss or damge, please report it to your host.
WC QUADRANGLE
CLINICAL CHEMISTRY
Normally, whilst on site you will be accompanied by your host or another member of staff or you will have been given instructions on how to reach a department and to whom you should report. Whilst in a department should you, for any reason, be left on your own, do not enter any other areas unaccompanied. Laboratories by their very nature contain many potential hazards. Entering them without being aware of these may expose you to some risk. Please ensure you wash your hands before leaving a laboratory area.
Laboratory Plans
CORRIDOR
Laboratory Safety
AU400
MEDIA
WRITE-UP / STUDY
SPECIAL ASSAYS
TOXICOLOGY
STORE
LIFT
OFFICE
Doncaster Histology
OFFICE
HPLC
PREPARATION
FRIDGES CENTRIFUGES
STORE
IMMUNOLOGY
BASEMENT CORRIDOR
PLANT ROOM
SAMPLE PROCESSING
Doncaster Level 3
CLEANER
SAMPLE PROCESSING
STORE
OFFICE
STORE
WC OFFICE
OFFICE WC
STORE
STORE WC DARK ROOM
STORE
MICROBIOLOGY
CYTOLOGY
OFFICE OFFICE OFFICE OFFICE OFFICE
OFFICE
HIGH RISK
OFFICE
OFFICE
HIGH RISK
STORE
OFFICE
OFFICE
OFFICE
CYTOLOGY BOOKING IN
OFFICE
LIFT MICROBIOLOGY
WC
OFFICE
CUT-UP
OFFICE
TISSUE PROCESSING
OFFICE
HISTOLOGY
Compliance with these simple instructions will assist us in maintaining standards of safety and reduction of risk. They will also help to ensure that your stay is in no way marred by an accident. Please note: Smoking is not permitted in any area within the laboratories complex.
FIRE DOORS
AUTOCLAVING
SECURED EXITS
AUTOCLAVES
Doncaster Level 2
STAFF ROOM
Advice
OFFICE
The laboratories are well equipped with fire alarm systems. However, these may vary depending upon the laboratory you are visiting. Your host will inform you of the evacuation procedure and the assembly point. Should the alarm sound, please leave the building with your host and do not go to collect personal belongings. If you are alone and the alarm sounds leave the building by the nearest emergency exit. Once outside proceed to the assembly point with the other staff. Please ask a member of staff if they can contact your host to inform them that you are out of the building. You may re-enter the building only on instruction from your host once they have been given the all clear.
MICROBIOLOGY
SAMPLE TUBE GUIDE
SAMPLE STORAGE
Draw tubes in the order given
Specimen Type
Tests
Short term
Time Limit
Longer term
Transport on Ice
10 mins
Not possible
FBC, film Blood Bank
Ambient
4 - 6 hrs
4 - 10° C
HbA1c
Ambient
Blood gas syringe
Blood EDTA
Transport
PTH
ACTH
Electrolytes
Pre-Chilled Tube On Ice Pre-Chilled Tube On Ice Ambient
requirements
Do not use air transport tube
Coagulation Screen, Prothrombin SODIUM CITRATE 1:9 Time (INR), APTT, Thrombophilia Fill to line essential
PLAIN Procollagen, Lamotrigine (No Additive)
Ambient
SST
10 -15 mins
Not possible
On Ice
10 - 15 mins
Not possible
On Ice
4 - 6 hrs
Available
HEPARIN
Blood SST Other Tests
Ambient
4 - 10° C
See Tube Guide
Ambient
Ambient
Blood See Sodium Tube Guide Citrate 1:9
Ambient
Blood Heparin
Blood Fluoride Oxalate Blood Culture bottles
Ambient
Lactate
Transport on Ice
10 mins
Culture & Sensitivity
37° C ASAP
Overnight
Biochemistry Ambient
Urine Universal
Culture & Sensitivity
4 - 10° C
Advice
24Hr Urine Collection Biochemistry Ambient Swabs
Culture & Sensitivity
4 - 10° C
EDTA
8 hrs max
Glucose, Alcohol
Screen, Lupus Anticoagulant Screen
Ambient
All Biochemistry Tests not mentioned elsewhere (1 Tube), Microbiology Tests (1 Tube), Immunology Tests Chromosome Studies, Lead, Amino Acids, Troponin, Synovial fluids for Crystals
FBC, Reticulocytes, Sickle Screen, Haemoglobinopathy Screen, G6PD, GF Test, PV, Malarial Parasites, ZPP, RBC Folate, Marker Studies, Lead, Complement, HbA1c, PCR Tests, HIV / CMV Viral loads, HLA B27, Kleihauer
EDTA (X-Match)
Blood Group, Save Serum, Crossmatch, Blood Group Antibodies, Cord Blood Samples
FLUORIDE OXALATE
Glucose, Ethanol (Alcohol), Lactate
On Ice
Do not use air transport tube Do not use air transport 4 - 10° C 4 - 6 hrs tube Do not use Specimens Overnight over 24 hrs air transport tube will be rejected Specimens over 12 hrs 12 hrs may be rejected 37° C
Overnight
SODIUM HEPARIN
Copper, Selenium, Zinc
Let's get it right ! SURNAME FORENAME
HIGH RISK CASES All specimens and request forms from patients known or suspected of having Hepatitis B, Hepatitis C or HIV infection MUST be identified with "DANGER OF INFECTION" labels. Other "high risk" infectious agents which should be notified are listed in the Microbiology section of the Laboratory BIOHAZARD Handbook.
DOB 12/12/1864 TIME1.30PMDATE 5/4/05 X2 SIG. Jo Bloggs 123 456 7890
WARD NO.
All samples should be transported to the laboratory as soon as possible
SMITH JOHN
Let's get it write ! Follow the Trust policy (PAT/T8) and avoid mistakes by labelling all types of samples correctly with the full name,date of birth and ID number using clear handwriting rather than the proven risk of the wrong sticky label Remember Transfusion samples must have all details and be signed
Uncontrolled copy for temporary use only - Please refer to laboratory handbook for current information
Sample Stability
Pathology services encompass the Departments of Clinical Biochemistry, Haematology, Histopathology, Cytology, Morbid Anatomy, Microbiology, Virology and Immunology. Pathology Laboratories are situated on the Doncaster Royal Infirmary and Bassetlaw District General Hospital sites. Phlebotomy services are also available on the Montagu site. OPENING HOURS The laboratories are generally open from 9.00 am - 5.00pm Monday to Friday. Please see Laboratory Handbook department sections for precise opening hours. OUT OF HOURS ACCESS Saturday, Sunday, Bank Holiday and after 5.00 pm Monday to Friday Emergency requests for Clinical Biochemistry, Haematology and Microbiology, contact the on-call BMS via the Switchboard. PATHOLOGY REPORT DELIVERY Pathology results are available electronically via PAS at ward level or via the GP electronic links. Hard copies are returned daily Monday - Friday. PATHOLOGY ENQUIRIES Can be made to either site regardless of which laboratory sample sent to: Direct 01302 553131 Doncaster Internal 3131 (713131 from BDGH) Direct 01909 502344 Bassetlaw Internal 2344 (752344 from DRI)
www.dbh.nhs.uk PD-UserHbk-03
PHLEBOTOMY SERVICE
MICROBIOLOGY SAMPLES
POINT OF CARE TESTING
In Patient Service A mornings only phlebotomy service is available to the wards at BDGH (Ext 2364) and DRI (Ext 3875) seven days per week. Monday to Friday Each ward will be visited by a member of the phlebotomy team who will take the request forms & bleed patients as required provided that they are wearing appropriate wristbands. On no account will the phlebotomist return to a ward that day. Saturday, Sunday and Public Holidays A reduced number of staff cover this time and requests should be kept to a minimum i.e. those tests that are necessary for immediate patient management only. The forms should be available from 07:00 & the phlebotomist WILL NOT return to any area after the initial visit. Please note that National Guidelines will be followed in that any patient not wearing the appropriate wristband will not be bled.
All urgent requests to be telephoned to Microbiology in advance. Please use the combined Pathology request form. When requesting investigations for Microbiology please do not mix with samples for other departments. It is essential that when requesting Virology investigations a separate request form is completed to accompany the sample. All Microbiology out of hours samples should be taken and stored in the specimen reception refrigerators or incubator as indicated below. Blood Cultures - Incubator Urines, Swabs, all other Microbiology samples - Refrigerator
Point of care testing (POCT) is defined as any form of diagnostic testing undertaken outside of an accredited laboratory environment. There are increasing expressions of interest in the use of POCT equipment outside the laboratory, particularly by general practitioners. The use of POCT equipment within the Trust is currently mainly limited to blood gas analysis on specific wards, glucose analysis throughout the hospital and the use of urine dip stix and pregnancy tests.
Out Patient Service A phlebotomy service is provided in the outpatient department at BDGH, Pathology Blood Tests at DRI and Pathology Blood Tests at Montagu, five days per week. The opening times for all hospital sites are 08:30 to 16:30. This service is for the venepuncture of outpatient clinic and General Practitioner patients. It is not generally necessary to make an appointment for blood tests, the exception being for Glucose Tolerance Tests, when appointments must be made by phoning Pathology enquiries. For certain investigations (ESR for example) the patient must attend before 16:00
Advice
URGENT / FAST TRACK The fast track service is only available from the departments of Clinical Biochemistry and Haematology from 09.00 - 17.00 Monday to Friday. A sample will only be accepted as fast track if the department receives a telephone call BEFORE the sample is received. Work will be analysed as routine if there is no phone call or if the sample is already in the laboratory when the phone call is received. Processing time is subject to equipment availability, and is timed from when the sample arrives at the laboratory. PROTOCOL Take the sample and complete the appropriate request form. Write "FAST TRACK" on the request form. Telephone Pathology Reception (DRI 3860 BDGH 2344) with the following information: Your name and location Patients name Test(s) required and the reason for the urgent request Details of route for result (Phone No./Bleep No./on VDU) Send the sample to Pathology Reception either: via the Tube system or via Service Assistant
BLOOD BANK Urgent Requests for Blood Bank must be telephoned directly to Ext 3799 DRI or Ext 2452 BDGH Ensure all specimens are labelled immediately after taking sample whilst at the patient's bedside. Refer to Trust Transfusion Policy PAT/T2 v2
CLINICAL BIOCHEMISTRY PROFILES BLOOD GAS PROFILE Anaerobic Heparin Arterial Blood - Gas Syringe pO2, pCO2, pH, Total hydrogen ion, Base excess/deficit, Standard bicarbonate BONE PROFILE SST Total Protein, Albumin, Globulin, Alkaline Phosphatase, Calcium, Corrected Calcium, Phosphate LIVER PROFILE SST Total Protein, Albumin, Globulin, AST, Alkaline Phosphatase, Gamma-GT, Total Bilirubin, Conjugated Bilirubin measured if total bilirubin >50Âľl/L U&E PROFILE SST Creatinine, Urea, Sodium, Potassium, Chloride. Bicarbonate available by specific request only LIPID PROFILE SST Triglyceride, Cholesterol, HDL-Cholesterol, Calculated LDL-Cholesterol, Cholesterol / HDL-Cholesterol ratio THYROID FUNCTION TEST SST TSH, Free Thyroxine (FT4)
SAMPLES - HEALTH & SAFETY Never eat, drink or smoke when transporting specimens & wash your hands frequently. Carry all specimens in the approved specimen container - not in your pockets.
The Directorate of Pathology has overall responsibility for the point of care use of the blood gas analysers and glucose meters. The Trust established a multidisciplinary Point of Care Testing Governance Committee in September 2003 and is chaired by Dr Jean Wardell, Consultant Biochemist and Clinical Director for Pathology. It is recommended that the need for POCT is always discussed with the relevant pathology laboratory in the first instance. A Trust Policy and Guidelines for Point of Care Testing (CORP/RISK8) has been produced and can be accessed from the Trust website. For other information contact our POCT Co-ordinator on 6115 (DRI)
LABORATORY LINKS Pathology results are available to the majority of users in electronic format. Whilst the directorate makes every effort to ensure the timeliness and accuracy of its reporting, there are times when the systems fail. If you are not able to receive results electronically or if you have any enquiries with regard to electronic issue of results, please contact the Pathology IT manager on 01302 381449 or email peter.taylor@dbh.nhs.uk.
TRANSFUSION PRACTITIONER The Trust has a Specialist Practitioner of Transfusion (SPOT) team. They can be contacted via switchboard on pager 07659504563 Monday to Friday 09:00 to 17:00. They are available for advice on all aspects of transfusion. and alternatives to transfusion. They are sensitive to religious and cultural issues surrounding transfusion of blood and products.
If there is a specimen breakage and spillage, isolate the area to prevent access and if you have an accident involving contamination with a specimen, contact a senior member of staff in the clinical or laboratory area.
QUALITY ASSURANCE
The tissue fixative for routine histology specimens is 10% formalin (a 4% solution of formaldehyde). This is a hazardous chemical, which should be handled with care. The laboratory can advise on storage handling and substance monitoring.
All departments aim to give the very highest quality of service with the minimum of delay. To ensure this, all departments participate in recognised external quality assurnace schemes. There are also extensive internal quality control checks. Any problems regarding the quality of the service should be brought to the attention of the Pathology Quality Manager on 01302 381473 or email fiona.dunn@dbh.nhs.uk
Please refer to Trust Standard Precautions policy PAT/IC19 available on the website.
Directorate of Pathology
Bassetlaw
Road Network
Hospital Site
Pathology Main Reception
Entry route Car Park entrance
Pay and Display Parking
Main Reception At Clinical Therapyentrance go up stairs / lift to second floor, Pathology Laboratory reception is slightly to the left and across from you as you come out of the stairs.
COAGULATION BLOOD BANK
HAEMATOLOGY
STORE
RECEPTION
WC
OFFICE
ON CALL ROOM
OFFICE
CORRIDOR
STORE OFFICE
STAFF ROOM
SEMINAR ROOM
WC
POST ROOM
QUADRANGLE
Advice
OFFICE OFFICE
OFFICE OFFICE
OFFICE
CLINICAL CHEMISTRY
OFFICE
OFFICE
VIROLOGY MICROBIOLOGY
OFFICE
AUTO CLAVES
BOOKING IN AREA OFFICE
SECURED EXITS
FIRE DOORS
Directorate of Pathology Road Network
Hospital Site
Pay and Display Parking
Pay and Display Parking
Entry route via Gate 3 Car Park A&E entrance
Pathology Main Reception Histopathology
Main Reception Enter at Accident and Emergency Entrance. Turn immediately right and then left along corridor. Pathology Reception is the second entrance on the right hand side of the corridor.
OFFICE
WC WC
HAEMATOLOGY
OFFICE
RECEPTION
OFFICE
PHLEBOTOMY
Histopathology Proceed beyond Pathology Main Reception, turn right and then down stairs. At foot of stairs turn right through doors and enter first doors on right. Report to Histology Secretaries
OFFICE
STORE
OFFICE WC OFFICE OFFICE
WC
OFFICE
PLANTROOM
OFFICE STORE
OFFICE
Advice
OFFICE
DARK ROOM CYTOLOGY
WAITINGROOM
CUT-UP
CLEANER
COAGULATION
STORE OFFICE
WC
WC
HIGH RISK
OFFICE
OFFICE
CYTOLOGY BOOKING IN
OFFICE STAFF ROOM
STORE
OFFICE HISTOLOGY WC BLOODBANK
From A&E Entrance by Gate 3 Car Park
Directorate of Pathology Road Network
Hospital Site
Advice
Entry route via Gate 3 Car Park A&E entrance
Pay and Display Parking
Sender The sender must ensure that the samples are in the correct container for transportation and that the patient's confidentiality is maintained by ensuring the form is not visible to the person transporting it. Samples sent from Pathology department are normally taken by Transport department and it is the senders' responsibility to organise this.
Bassetlaw District General Hospital Weekdays 9.00am - 5.00pm All samples should be taken to Pathology Specimen Reception. All other times All samples should be taken to Pathology Specimen Reception. Please ring the bell located on the entry keypad to inform staff that samples are being delivered.
Doncaster Royal Infirmary Weekdays 9.00am - 5.00pm Blood Bank samples - Take directly to Blood Bank Histology samples - Take directly to Histopathology department All other samples - All samples should be taken to Pathology Specimen Reception. All other times All samples should be taken to Pathology Specimen Reception. Please ring the bell at reception to inform on call Biomedical Scientist and leave the samples in the green basket attached to the shutter, not on the floor or just outside the Blood bank door.
Mexborough Montagu Hospital Weekdays 9.00am - 5.00pm All samples should be taken to the laboratory at Mexborough for transportation to DRI at 10:45, 12:45 and 15:30. There is an additional transport run at 17:00 from Barnburgh ward, so all samples for that run should be sent there by the person requesting the tests. All other times All samples should be taken to Barnburgh or Adwick ward for pick up by the driver and it is the responsibility of the person requesting the test to arrange suitable transport.
Version 1.0 - March 2007
Advice
Conditions > > > >
Do not open the box Do not place the box in sunlight or next to the heater outlet Ensure the box is secure and unable to move around If there is a delay in transportation due to traffic difficulties etc, the driver must contact the transport department immediately or as soon as it is safe to do so 01909 500990 Ext 2424. If this defaults to an answer machine the driver must contact the BMS on call in Haematology via switchboard immediately 01302 366666 or 01909 500990
Formalin Specimen pots for histology samples will be in a chemical fixative solution called formalin (also known as formaldehyde) which can be hazardous if transported inappropriately. Drivers should have relevant health and safety guidance and instruction in what to do in the event of a spillage of the formalin chemical.
Bassetlaw District General Hospital Main Reception
COAGULATION BLOOD BANK
At Clinical Therapyentrance go up stairs / lift to second floor, Pathology Laboratory reception is slightly to the left and across from you as you come out of the stairs.
HAEMATOLOGY
STORE
Pathology Specimen Reception
WC
OFFICE
ON CALL ROOM
OFFICE
Pathology Main Reception
CORRIDOR
STORE OFFICE
Hospital Site
RECEPTION
STAFF ROOM
SEMINAR ROOM
WC
POST ROOM
QUADRANGLE
OFFICE OFFICE
OFFICE OFFICE
OFFICE
CLINICAL CHEMISTRY
OFFICE
OFFICE
Entry route Car Park entrance VIROLOGY MICROBIOLOGY
Pay and Display Parking OFFICE
AUTO CLAVES
BOOKING IN AREA OFFICE
Pathology Specimen Reception
HAEMATOLOGY
STORE
Histopathology
OFFICE
Proceed beyond Pathology Main Reception, turn right and then down stairs. At foot of stairs turn left through doors and enter first doors on left.
WC WC
OFFICE
RECEPTION
OFFICE
STORE
OFFICE
OFFICE OFFICE
WC
STORE
Enter at Accident and Emergency Entrance. Turn immediately right and then left along corridor.
OFFICE
Main Reception
ON CALL ROOM
Doncaster Royal Infirmary
OFFICE
WC
OFFICE
WC
WC
Blood Bank Reception
OFFICE
DARK ROOM
CUT-UP
STORE
CLEANER
OFFICE STORE
STORE
CYTOLOGY
HIGH RISK
TISSUE PROCESSING
OFFICE
Histology Specimen Reception
SAMPLE PROCESSING
COAGULATION
BASEMENT CORRIDOR
WAITING ROOM
SAMPLE PROCESSING
OFFICE
QUADRANGLE
PHLEBOTOMY
LEVEL 1 - CLINICAL CHEMISTRY
CORRIDOR
OFFICE
PLANT ROOM
OFFICE
OFFICE
CYTOLOGY BOOKING IN
STAFF ROOM
STORE
OFFICE HISTOLOGY WC BLOOD BANK
Hospital Site
Pay and Display Parking
Pay and Display Parking
Entry route via Gate 3 Car Park A&E entrance
Pathology Main Reception Histopathology
Mexborough Montagu Hospital
Version 1.0 - March 2007
Advice
Hospital Site
Pay and Display Parking
Pathology Reception