Click here for the list of Molecular Pathology UKAS accredited Assays

Introduction to The Molecular Pathology Diagnostic Service

The discipline of Molecular Pathology encompasses those investigations which determine the diagnostic, prognostic and predictive profile of pathology specimens through the analysis of alterations to DNA, RNA or-in certain cases-Proteins. This can include small mutations or large chromosomal aberrations, DNA methylation, and changes to RNA transcription and protein expression levels.

Service Background

The Molecular Pathology Diagnostic Service (MPDS) provides a diagnostic molecular pathology service to internal users within the Trust, external users regional; national and international. The department processes over 20,000 samples per year and offers services in both solid tumour testing and circulating tumour DNA.

The department utilizes a broad range of molecular techniques including immunohistochemistry, FISH, PCR based targeted assays (Sanger Sequencing, real time PCR, pyrosequencing) and next generation sequencing (NGS) to provide testing for protein expression, gene mutation, gene methylation, gene amplification and chromosome translocation. 

The laboratory is accredited to ISO 15189:2012. Tests that fall under this scope can be found using the link above and is also indicted in the 'Test Repertoire' section below.

The department of Molecular Pathology is part of Clinical Laboratory Services and operates within the Quality Management System of the Clinical Laboratory Services, it is led by a Consultant Clinical Service Lead, a Principal Clinical Scientist and an Operations Manager. MPDS participates fully in UK NEQAS and GENQA External Quality Assurance schemes where appropriate.

MPDS provides a comprehensive molecular pathology service to the Trust, and nationally, between 8:30 and 17:00 Monday - Friday. Please contact the laboratory for any pricing enquiries.

Contacting The Laboratory

Several key personnel are involved with the management of the department at QEHB. For general enquiries, please contact the Specimen Reception.

Requesting a Test

In order to process specimens efficiently, it is essential that request forms are fully completed in a clear and legible format. The use of patient ID stickers is permitted however please ensure you use the full patient sticker NOT the smaller blood tube sticker. All specimens received into MPDS must meet the agreed laboratory minimum data set; any specimens not meeting the criteria may be returned to the requesting department. Please ensure that any important information (e.g. clinical history, etc.) is clearly indicated on the form and ensure that any priority or urgent cases are marked as such.

Click the link below to view and download the latest versions of our request forms.

Molecular Testing Request Forms

Minimum Data set Required

Data on the request form and the specimen must be compatible. All specimens must carry a minimum, legible and compatible data-set on both the request form and the specimen label. Where possible a copy of the pathology report should be provided.

Sending Samples To Us & Subsequent Return of Material

For information on how to send samples to MPDS including packaging and transport, and information on the return of samples, please click here.

Molecular Test Repertoire & Turnaround Times

From the 1st September 2020 onwards, the FISH service previously provided by the ROH Pathology Department will be transferred to the Molecular Pathology Diagnostic Service (MPDS) based at the QEHB.

All FISH tests previously performed in the ROH Pathology Laboratory have been validated again at the QEHB site following UKAS standards; these tests are awaiting submission for consideration within an extension to scope (ETS) application for accreditation. In the mean time, those tests will not fall under our scope of accredited tests but will be performed within our ISO accredited Laboratory.

Any external requests should be made to MPDS directly, as below. If you have any query, please feel free calling or/and emailing us.

Breast Cancers

The section offers a comprehensive HER2analysis service for breast cancers. Immunohistochemistry, with the Roche/Ventana 4B5 antibody, is used to screen patients for expression levels of the HER2 protein and identify those “over-expressers” who are most likely to benefit from treatment with Trastuzumab (Herceptin). Where expression levels are equivocal, FISH is used to determine amplification at the gene level. Service users may access the full service, or submit cases for FISH analysis only if performing their own IHC.

Gastric Cancers

As with breast cancers, HER2 analysis is performed in Gastric cancers to assist in predicting which therapies patients will benefit from. As well as this standard-of-care testing, mismatch-repair analysis and ISH for EBV are also available on demand.

Colorectal Cancers

RAS (KRAS and NRAS) mutations confer resistance to anti-EGFR monoclonal antibodies, and act as a negative predictive marker for these therapies.  The National Institute for Clinical Excellence (NICE) has approved the use of Cetuximab and Panitumumab for the treatment of metastatic colorectal cancer in patients who carry normal, “wild-type” RAS genes. RAS testing is mandatory prior to their prescription.

BRAF gene mutation analysis is provided on demand for colorectal cancer patients. This can be used to inform patient management or, in combination with mismatch repair expression (see below), to help establish the presence of the inherited cancer syndrome HNPCC (Lynch syndrome).

We are a reference centre for Mismatch repair(MMR) protein expression analysis in patients suspected to have Lynch syndrome; we test over 700 cases a year. immunohistochemical testing allows identification of patients without normal DNA repair processes, who are therefore more likely to have Lynch syndrome. In patients with MLH1 loss we can also perform reflex testing for BRAF V600E mutations and MLH1 promoter methylation status. Mismatch repair protein expression is also requested increasingly to help inform patient chemotherapy decisions, as patients lacking MMR expression appear to have reduced sensitivity to certain cytotoxic treatments.

BRAF p.Val600Glu (“V600E”) specific immunohistochemistry (IHC) is available on demand.

Lung Cancers

EGFR mutations correlate with the effectiveness of certain Tyrosine Kinase Inhibitors (TKIs) such as Gefitinib, Erlotinib, Afatinib, and Osimertinib against some Non-Small Cell Lung Cancers (NSCLCs). Activating mutations are reported to correlate with significant responses to such treatment, whilst certain other mutations correlate with resistance to first- and second-generation TKIs, but predict response to newer agents. EGFR mutation status is therefore vital in deciding the most appropriate treatment regime. The service also offers EGFR analysis on circulating tumour DNA extracted from plasma. This is of particular use in testing patients for acquired, targetable secondary mutations when they begin to progress whilst on treatment that targets their primary EGFR mutation. It may also function as a surrogate where clinical circumstances make obtaining a more representative tissue specimen for initial diagnostic testing difficult or impossible. The service can provide specialised collection tubes for users wishing to submit samples.

Anaplastic lymphoma kinase (ALK) gene fusions can be targeted with specific inhibitors, and translocation analysis using immunohistochemistry or Fluorescence In-Situ Hybridisation (FISH) is now standard alongside EGFR mutation analysis to determine 1^st line treatment for lung NSCLC. In addition to ALK analysis, the service provides FISH and IHC testing for ROS1 fusions in lung cancer. 

PD-L1 expression analysis is also important in informing first (and second) line anti PD-1 / anti-PD-L1 monoclonal antibody treatment for lung NSCLC. A relatively recent addition to the testing landscape, in 2016, immunohistochemical analysis using companion-diagnostic antibodies specific to the relevant treatments gives a quantitative expression result.

Gastrointestinal Stromal Tumours (GIST)

Up to 90% of all malignant GISTs harbour gain-of function mutations in the KIT / PDGFRA genes. Primary mutations have been described in exons 8, 9, 11, 13 & 17 of KIT, and exons 12, 14 & 18 of PDGFRA. Secondary (acquired or treatment associated) mutations have also been described. Selective TKIs have a high response rate in patients with advanced GISTs, which are largely radiotherapy and chemotherapy resistant. Evidence suggests that the type and location of KIT or PDGFRA mutations in GISTs predicts the response to TKI treatment.

Melanomas

The BRAF gene is frequently mutated in human melanomas, with mutations seen in 35-50% of cases. Mutations lead to constitutive activation and aberrant signalling, and subsequent malignant behaviour. Drugs that treat those cancers by inhibiting BRAF are now licensed for use in metastatic disease.

The NRAS gene is also frequently mutated in melanoma; between 10-20% of tumours show an NRAS mutation, and these are thought to be mutually exclusive with alterations in BRAF. NRAS testing is offered as a supporting aid in selecting patients for access to novel therapeutic interventions or clinical trials targeting the pathway activated by mutant NRAS.

Mutations in the KIT gene are seen in Acral and mucosal melanomas and represent potential therapeutic targets.

PD-1 and PD-L1 inhibition, particularly in combination with anti-CTLA4 therapies, has shown profound and sustained effects against metastatic melanoma. Whilst PD-L1 expression analysis is not mandatory for prescription, as it is with some lung NSCLC therapies, it has been shown to be helpful in informing decisions on whether to use mono- or combination-therapy.

Brain Tumours

The revision of the WHO classification of CNS tumours in 2016 has expanded the range of essential and desirable molecular analyses performed.

Epigenetic silencing of the MGMT(O6-methylguanine–DNA methyltransferase) gene by promoter methylation is associated with longer overall survival in patients with glioblastoma who, in addition to radiotherapy, received alkylating chemotherapy with temozolomide. High levels of MGMT activity in cancer cells create a resistant phenotype by hindering the therapeutic effect of alkylating agents and may be an important determinant of treatment failure.

Combined loss of chromosome arms 1p and 19q (denoted as 1p-/19q-) is a powerful predictor of chemotherapeutic response and survival in oligodendrogliomas. A FISH based analysis of these loci is available as a tool to assist patient management. More recently it has been employed diagnostically in the differentiation of ATRX-positive Oligodendrogliomas and Astrocytomas.

Mutation analysis of the IDH1 and IDH2 genes is used as a supplement to immunohistochemistry. Whilst the IDH1 R132H-specific antibody detects the majority of IDH mutated tumours, mutation analysis for rarer R132 variants along with IDH R100 and IDH2 R172 mutations is used in particular relevant clinical scenarios.

Turnaround Times

Turnaround Times from sample receipt to result issued are variable dependent on the test requested.

Service users are advised to directly contact the service in instances where a shorter turnaround time is essential for patient management, or where a report has not reached them within the stated turnaround time.

Reporting

Specimens are reported on the Laboratory Information Management System. For internal patients the reports are then automatically uploaded to the Clinical Portal For external users, reporting is provided electronically. A list of recipients and nhs.net email addresses is required. All reports are stored with the laboratory LIMS system indefinitely.

The department will not send reports by Faxitron.

Members of MPDS are available from 08:30 – 17:00 Monday – Friday for the reporting of specimens and to offer advice. 

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UKAS ACCREDITED ASSAYS

Blood Transfusion carries risk and good clinical practice requires that blood components should be prescribed only when the benefit to the patient is likely to outweigh the risks. Prescription of these components shall be in conjunction with the Maximum Surgical Blood Ordering Schedule (MSBOS) and Trust Transfusion Policy all of which can be found on the Trust Intranet.

The requirement for transfusion of blood or blood components shall be recorded in the notes prior to completing a request form. The patient should be informed that they require a transfusion and given the appropriate information leaflets if circumstances allow. These should available in all clinical areas. The component type and quantity required should be requested in conjunction with the above guidance, to request further information leaflets contact the Hospital Transfusion Practitioner on ext. 15966.

A comprehensive guide to UHB Transfusion Services, Guidelines, Sample Requirements and Indications for Blood Use can be found in the Blood Transfusion Policy and its linked Procedures 1-8 available on the Trust Intranet

The guidelines have been drawn up in line with nationally agreed indication codes and recommendations

Laboratory hours and telephone numbers are as listed under Laboratory Haematology Contact QEHB Blood Bank on ext. 13297/8 or bleep 1376, there is a member of staff on duty 24/7.

Samples for complex red cell, platelet and granulocyte antibody tests, will be referred to the NHSBT. It is recommended that if patients require these investigations it should be discussed with a Clinical H

All requests for blood or blood components (red cells, plasma, platelets and cryoprecipitate) should be made on the request form or by telephoning blood bank, if there is already a valid group and save available. Please note blood bank have a two sample rule, which requires all patients to have a historical blood group on file along with a current valid group and save prior to any crossmatched blood being issued. All urgent requests should be discussed with blood bank so they can process the samples as a priority.

All patients requiring a blood transfusion are required to have a historic blood group on file and a current valid group and save prior to receiving any crossmatched blood.

There is zero tolerance regarding sample labelling and requesting in blood bank. Only samples that meet the following criteria will be accepted:

• All samples must be hand written onto the bottle label, sticky labels of any kind are not acceptable.
• The details on the sample and request card must match.
• Pre-printed addressographs are acceptable on the request form but should be initialled.
• On the sample and the form there must be;
  • Registration number.
  • Surname.
  • Forename.
  • Date of Birth.
  • Gender.

In addition to this the form must also have:-

• Consultant details.
• A contact number.
• Reason for the request.
• Location of patient.
• Phlebotomist’s name.
• Signature of the requestor.
• Date and time when sample drawn.
• Type of Request i.e. G&S, Crossmatch and number of units if required.
• Special Instructions - The laboratory must be informed if these are required
  • e.g. Irradiated, CMV negative, HLA selected, sickle negative etc.

Information on the request form and the blood tube should be double-checked to ensure that it is both complete and correct. Patient information on the blood tube must be taken from the patient not the form.

In an emergency, the registration number, gender and phonetic trauma name will be acceptable.

Blood transfusion errors are most often those of patient identification. Full details on patient identification can be found on the Blood Transfusion Policy Procedure 2. Patients identity much be confirmed by asking the patient to state their

• First and Surname
• Date of Birth
• Check this information and the hospital registration number against the wrist band and request form.

Prothrombin complex concentrate (Beriplex)

Available from the emergency pharmacy fridges at QEH. Guidelines for use are on the hospital intranet under P (Prothrombin complex concentrate)

See Guidelines on trust intranet for the use of Prothrombin Complex Concentrate (Beriplex) in life-threatening haemorrhage in patients on warfarin or acquired deficiency of vitamin K dependant clotting factors.

Albumin

Obtained from Pharmacy

Activated factor VII - rFVIIa (Novoseven)

Available from emergency pharmacy fridges at QEH.

Guidelines for use are on the hospital intranet for the use of recombinant activated factor VII (NOVOSEVEN) in life-threatening uncontrolled haemorrhage.

Anti D

Obtained from the Women’s Unit after consultation with Haematology Medical staff

If unsure discuss the use of these products with Blood Bank or Haematology medical staff.

Cellular Pathology is based across UHB sites at QE Hospital Birmingham, at Birmingham Heartlands Hospital, Solihull Hospital and at Good Hope Hospital.

The majority but not all of Cellular Pathology tests that are performed and equipment in use are accredited to internationally recognised standards for medical laboratories ISO 15189.  This is important for the Department and for service users as it provides assurance on quality and competence.   There is increasingly an integrated approach across  the different UHB hospital sites where staff, equipment and testing may be shared to deliver the highest possible quality services to our service users. The full range and nature of accredited tests is detailed on the United Kingdom Accreditation Service website https://www.ukas.com 10141 Schedule of Accreditation .

At the QE site the laboratory has recently updated equipment H&E, special stains and immunohistochemistry staining platforms to support high quality diagnostic cellular pathology reporting and to ensure full traceability of samples within the laboratory.  Other new tests to meet clinical requirements are regularly added to the testing repertoire.  Consequently not all platforms, special stains and antibodies have been assessed by UKAS and so will not currently be covered by published UKAS Accreditation scope to ISO15189.   

The Department is currently supporting the Trust with significant increases in clinical activity.  For some specialties reporting times have fallen bellow targets and so the Department is working with service users to minimise the impact of this.  The Department is prioritising clinically urgent requests and patients on cancer pathways, recruiting and working additional sessions.  The Department is also outsourcing reporting of some requests to two external specialist UKAS Accredited suppliers that hold contracts with the Trust.

Specialist Services  within Cellular Pathology (by site), QE=Queen Elizabeth, BHH=Birmingham Heartlands, SH = Solihull, GH=Good Hope

• MOHS (QE, SH) -   microscopically controlled surgery used to treat common types of skin cancer. 
• Neuropathological Smears (QE) -  rapid diagnostic service for intra-operative brain tissue specimens
• Cytopathology (BHH,QE) - diagnostic cytopathology services for the Trust including fine needle aspirations, endoscopic brushings and washings, EUS-FNAs , serous fluids urines and CSF.  
• Muscle Biopsy Service (QE) -  part of the investigation of a clinically suspected neuromuscular disorder when other less invasive tests have not provided a firm diagnosis.
• Electron Microscopy Service (QE) - used routinely at magnifications of between 1500 and 70,000 times to examine the ultrastructure of cells and their surroundings.   
• Andrology (GHH) - Diagnostic, Post Vasectomy and Retrograde  Semen analysis .  The service operates from a single site located on the 1st Floor of the Sheldon Unit at Good Hope Hospital.
• Direct Immunofluorescence (BHH and QE) - Direct immunofluorescence is used for the detection of  tissue bound proteins such as antibodies and complement proteins. Two types of tissue, skin or renal, are processed, This method allows for the detection of tissue bound antibodies when there may be insufficient levels to detect in serum.  
• Mortuary (QE, BHH, SH, GH) - Body storage available on all sites with 10 freezer storage spaces available on the Solihull sites.  Post Mortems can be carried out on the Heartlands and QE sites.    
• Immunohistochemistry (QE,MSK, BHH) - carried out using different platforms and antibodies across the sites.  See attached UKAS scope for those antibodies accredited.  At present there are several antibodies that are not yet accredited but will be added to the scope in due course.      

Minimum Dataset required for Cellular Pathology Requests

In order to process specimens it is essential that request forms are fully completed in a clear and legible format. The use of patient ID stickers is permitted however please ensure you use the full patient sticker NOT the smaller blood tube sticker. All specimens received into Cellular Pathology must meet the agreed laboratory minimum dataset; any specimens not meeting the criteria will be returned to the requesting department.  Please ensure that any important information (e.g. clinical history, bleep number etc.) is clearly indicated on the form and ensure that any priority or urgent cases are marked as such.

• Trust users can make request via a theatre request book entry or by completing an internal UHB histopathology / cytopathology request form. 
• GP and dental practices should complete the external request form which can be supplied on request from the Department and for internal service users this link http://www.uhb.nhs.uk/gps/laboratory-information/ shows this request form together with specific request forms used within the Trust (QE site)  for liver and breast biopsy cases.  For Heartlands, Good Hope and Solihull users then request forms are available from the Department of via a request to This email address is being protected from spambots. You need JavaScript enabled to view it. 

TWO unique patient identifiers must be present on both the request form and specimen container i.e. a minimum of the PID, NHS number or the DOB together with the patient surname and forename/initial in order to be accepted by the department. Other missing data (e.g. full clinical details) may be clarified over the phone or by email as needed.

Sample pot requirements                                   

• Patients full name  (or as a minimum; surname with initial) 

• Hospital or clinic PID / NHS no. AND/OR Date of birth

Request form                                              

• Patient’s full name.                                 

• Date of birth.                                             

• Hospital or clinic PID / NHS no.

• Address

• Location

• Clinical details

• Request form must be signed

• Consultant / GP

If one or more than one specimen is taken from the same patient the specimen containers and request form must be clearly labelled with the sites of the spec and indicated as parts 1,2,3 etc.

Hazardous Specimens

Specimens arising from patients with known or suspected transmissible diseases (e.g. tuberculosis, viral hepatitis, HIV) must be clearly labelled as such to prevent unnecessary risk to laboratory staff.

Specimen Containers 

When requesting stock a member of staff from the Cellular Pathology department will inform the requestor when they will be ready for collection by the portering staff. Consumables provided by the lab should be transported via the porters so please allow time for preparation and transport.   External requests for sample pots and request forms are through contacting the Department.  For Heartlands site please e-mail This email address is being protected from spambots. You need JavaScript enabled to view it., for QE site use This email address is being protected from spambots. You need JavaScript enabled to view it. and for QE ROH/Bone requests This email address is being protected from spambots. You need JavaScript enabled to view it.

Transportation of Specimens

Specimens are collected at regular intervals from theatres and all relevant departments via portering services. Urgent and unfixed (dry/not in formalin) specimens should NOT be left until the next routine collection – telephone portering services and arrange for a member of staff to bring the sample(s) to the laboratory without delay.

Please note specimens must be despatched to the Department within a secondary bag or secure transport box with sufficient absorbent material to absorb/contain any potential spillage.  Formalin is a hazardous reagent with any leakages put portering, transport and laboratory staff at significant risk.  Please ensure containers are closed or sealed with appropriate fitting lids.  If in doubt please seek advice from the Department.

Urgent Reporting

Occasionally it may be necessary for a requesting clinician to highlight a specimen as clinically urgent. If an urgent report is required it should be clearly identified or indicated on the request form. Urgent requests should be sent to Cellular Pathology via the porters without delay.

To ensure that cases are not delayed within the laboratory please make sure that the request form is correctly completed and all sections are filled in properly. Once received urgent cases will be highlighted by the specimen reception and prioritised appropriately in the departmental workload.  

In addition to clinically urgent cases there are UHB wide @FDS@ or Faster Diagnosis Specification stamps to fast track these patient cancer samples.  This is to support end to pathways and prevent patient breaches where possible through prioritisation.

Service Background

The Department of Cellular Pathology provides a diagnostic histopathology, cytopathology, andrology, muscle biopsy, electron microscopy, Mohs, post mortem and mortuary service to internal users (other Trust departments e.g. surgery) as well as external users (GPs, dental and private practices). The Department also incorporates the Tissue services for the Trust; this Department is responsible for managing and ensuring compliance of the licensable activities which falls under the HTA Human Application Sector, this includes procurement, testing, storage, traceability, disposal and distribution of human tissue and cells for therapeutic use.

Cellular Pathology Department operates within the Quality Management System for Pathology Services and is led by a Clinical Service Lead Dr Bruce Tanchel.   A technical Service Manager, Head Biomedical Scientist, Martin Collard oversees the management of the Department. Cellular Pathology participates fully in UK NEQAS External Quality Assurance schemes where appropriate.  The Laboratory works to ISO 15189 requirements and is assessed by UKAS to evaluate compliance.  The vast majority of equipment, procedures and tests offered by the Department of Cellular Pathology are included in the UKAS scope of Accreditation seen here: https://www.ukas.com schedule 10141 .  Some non-accredited tests may also be used to support diagnostic tests and these are mainly reflected in stains, antibodies and associated platforms that are currently under assessment by UKAS for potential additions to the scope of laboratory testing. 

Some non-gynae cytology remains available at the QE Laboratory site but the majority of cytology samples across UHB are transferred to the Heartlands Hospital site for processing and staining.  The routine histopathology repertoire includes specialist renal, liver, muscle and nerve processing and reporting and a well established electron microscopy service.  During 2022/23 the former Musculoskeletal Pathology laboratory moved across to the QE Cellular Pathology site and details of this major service change will follow as part of the project planning process.  This specialty within Cellular Pathology is referred to as the Bone and Soft Tissue Unit.

The Department provides a comprehensive pathology service to the Trust, South Birmingham Community and Mental Health Trusts, Private Hospitals, General Practitioners and General Dental Practitioners.  The core laboratory sites are open Mon-Fri between 08:00 and 17:30 with QE Cell Path also open Sun 07:00-15:00 and Heartlands Cell Path Sat 09:00-12.45. A specialist/expert referral service is also provided to hospitals in the West Midlands, nationally and to international clients.

The Department operates within the Quality Management System of the Clinical Laboratory Services and is led by both a consultant medical Clinical Service Lead and a technical Service Manager. Cellular Pathology participates fully in UK NEQAS External Quality Assurance where appropriate.

Personnel 

Specimen requirements

Routine Coagulation Testing:

The Coagulation section offers a 24 hour service for all routine coagulation testing, which includes Prothrombin time (PT/INR) Partial Thromboplastin Time (PTT), Fibrinogen level and D-Dimer assay. For urgent requests during core hours (08:00-20:00) please contact the laboratory on ext 15986 or 0121 3715986 to obtain an urgent reference number.

Special Coagulation Testing:

The coagulation section also offers a comprehensive range of specialist coagulation assays which are performed by prior arrangement. These include Factor Assays, Inhibitor Assays, Anti-Xa Assays, Thrombophilia screening, von Willebrand screening, Lupus screening, Heparin induced thrombocytopenia (HIT) screening, ADAMTS13 Activity/Inhibitor Assays and Platelet function testing. This service operates a 5 day working week from Monday to Friday 09:00-17:30. In certain circumstances urgent assays may be performed out of hours by prior arrangement. Refer to the information in the individual test database for sample requirements and for copies of the appropriate request form (external requests only). Please contact Haematology medical staff for further advice on any special coagulation requests. 

Special coagulation assays are complex to perform and are batch processed within 21 days of receipt, however urgent requests can usually be processed within 24 hours. Please contact the specialist coagulation laboratory on ext 15988 or 0121 3715988 to discuss any urgent requests.

Investigation of Coagulation Disorders request forms:

ADAMTS13 Activity/Inhibitor Click Here

All other specialist coagulation assays: Click Here

(links to these request forms can also be found in the test database) 

Sample collection notes:

The ratio of citrate anticoagulant to blood in the coagulation test tubes is critical and therefore these tubes must be filled to the black fill line indicated on the tube. It is important to ensure that the anticoagulant is mixed adequately with the blood as inadequate mixing may result in a degree of coagulation activation, which may cause abnormal laboratory results. It is also important to avoid tube contamination, for example do not tip blood from EDTA tubes into citrate tubes as this will interfere with coagulation test results. Blood should not be taken for coagulation studies via a line or indwelling catheter which has contained heparin. Even trace amounts of residual heparin will interfere with coagulation test results.

It is important that blood samples for coagulation tests are transported to the laboratory without delay, samples must not be refrigerated or stored overnight. Testing is most accurate if carried out within 4 hours of venepuncture. As the stability of coagulation factors varies, add on telephone requests will be performed at the discretion of the laboratory based on sample viability.

If tests are required on patients taking anticoagulant therapy, the anticoagulant must be stated clearly on the request form. This information ensures that tests are prioritised accordingly and also facilitates the interpretation of results. 

It is not practical to list all factors that may affect all analytes however but a guide to some of the more common factors are as follows:

• Haemolysis, icteric and lipaemia interfere with certain analytes and as a consequence some analytes may not be reported. However, a comment will be included on the report to indicate why. Common analytes affected include: sodium, potassium, bilirubin, magnesium, phosphate, LDH, AST, ALT and cTnT hs.
• Serum samples should be processed (centrifuged and serum separated from the cells) within 12 h of collection. Any undue delay, particularly more than 6 h, can influence the potassium and enzyme results.
• Extreme temperatures (cold and hot) can cause abnormal levels of some analytes especially potassium.
• Sodium is affected by abnormal levels of protein and lipids. A direct ISE measurement will be performed and this report (plus appropriate comment) will be issued.
• A high platelet and white blood count can cause a falsely elevated potassium (a condition known as pseudohyperkalaemia). It is suggested that in these suspected cases blood is collected into both a lithium heparin tube and a yellow top serum tube and sent to the Biochemistry department as soon as possible for potassium analysis to confirm. There is a difference of approximately 0.3 mmol/L in plasma compared with serum potassium. Larger differences are consistent with blood abnormalities affecting the results.
• It is important that blood is collected in the correct tubes and in the correct order to reduce the risk of anti-coagulant interference e.g. EDTA interference with calcium assays.
• CSF samples for xanthochromia should be protected from light and should not transported to the laboratory using the SDS. Lumbar puncture for xanthochromia should not be performed until 12 hours post onset of symptoms in order to minimise false negative results.
• HbA1c will not be reported on patients with known haemoglobinopathies. It is recommended that fructosamine is measured on these patients.

Standard 4 of the National Service Framework for Coronary Heart Disease states that:

“General Practitioners and Primary Health Care teams should identify all people at significant risk of cardiovascular disease (CVD) but who have not yet developed symptoms and offer them appropriate advice and treatment to reduce their risk”.

Numerous risk calculators are available to calculate risk for coronary disease and these are all based on the Framingham model. The JBS III or the QRISK 2016 calculators are used for the calculation of cardiovascular disease risk. The South Birmingham PCT requires general practice to screen for CVD and any request for ‘CVD risk’ will generate a total cholesterol, HDL-cholesterol, creatinine and HbA1c (a yellow top and purple top bottle must be supplied). There are freely available calculators available to calculate a ‘CHD risk’ (Coronary heart disease risk) score (e.g. http://www.qintervention.org/)

Please note HDL-cholesterol is only measured when the CHD risk score is requested. We do not provide HDL-cholesterol otherwise on any request for a lipid profile.

Often we are asked to provide LDL-cholesterol calculations. For your convenience the calculation of LDL-cholesterol is provided below but you should recognise that this is only strictly valid where patients attend fasting for at least 12 hours in order to suppress triglyceride concentrations. Triglyceride concentrations >4.5 mmol/L negate the use of the calculation;

LDL cholesterol = Total cholesterol – HDL-cholesterol – (Triglyceride/2.19)

Conventionally diabetes mellitus was diagnosed by high fasting or random blood glucose concentrations, or an abnormal oral glucose tolerance test (OGTT) whilst haemoglobin A1c (HbA1c) was used to monitor longer term glycaemic control in patients with known diabetes mellitus.

In 2011, the World Health Organisation (WHO 2011) recommended that HbA1c measurements should also be used to diagnose diabetes in the majority of asymptomatic individuals, and this recommendation has been agreed in the UK (NHS Diabetes 2011).

An HbA1c of 48 mmol/mol or more is consistent with diabetes. If the patient has no symptoms then a second HbA1c result must be obtained within 2 weeks, and if it remains ≥48 mmol/mol diabetes mellitus is confirmed.

HbA1c values of 42 to 47 mmol/mol suggest a high risk of future diabetes. Such individuals should be offered structured lifestyle education and support to delay/prevent development of diabetes, and have an annual HbA1c test.

HbA1c must be measured in an accredited laboratory undertaking recommended quality assurance procedures. Near patient testing is not appropriate when HbA1c is used for the diagnosis of diabetes.

HbA1c is now the preferred method to diagnose diabetes, except in the following situations where this test would be unreliable, and in whom the traditional methods of diagnosis with blood glucose concentrations remain the method of choice:

• Haemoglobinopathies
• Increased red cell turnover
• Anaemia (haemoglobin < 80 g/L)
• ?Type 1 diabetes or acute onset of symptoms of diabetes
• ?Gestational diabetes
• Children and adolescents
• Patients taking steroids and antipsychotic or other medications that cause a rapid rise in blood glucose

Despite this new approach, if an individual has abnormally high random or fasting blood glucose levels or abnormal OGTT, which would be consistent with diabetes on the traditional criteria, then that patient should be considered to have diabetes irrespective of their HbA1c value. Without symptoms of diabetes two abnormal tests of the same type (two high fasting/random blood glucoses or a diabetic OGTT) are required to confirm diabetes mellitus.

Contact the duty biochemist on 0121 3716543 to discuss whether an oral glucose tolerance test (OGTT) is required for a particular patient and/or to book an OGTT. The OGTT is performed at the Diabetes Centre Laboratory in Nuffield House on the QEHB site. In addition, a protocol can be provided for performing an OGTT on wards or in the community.

Introduction

Clinical Laboratory Services provides a high quality, cost-effective service to the University Hospital Birmingham NHS Foundation Trust, GPs and community hospitals mainly within the South Birmingham PCT and is a referral center for specialist services for other local; national Trusts and international users. It is continually upgrading the test repertoire offered to reflect medical development. The laboratory services currently provided include:

Department of Clinical Biochemistry
Department of Laboratory Haematology (Including Transfusion) Department of Clinical Microbiology (Including Virology) Department of Cellular Pathology
Department of Molecular Pathology

All laboratories are staffed by qualified and experienced medical, scientific and technical personnel.

Quality Management

Clinical Biochemistry, Laboratory Haematology, Blood Bank, Cellular Pathology, Molecular and Clinical Microbiology laboratories are subject to external accreditation by UKAS against ISO 15189.

Each of the laboratory departments runs a comprehensive quality management system, participating in all relevant National Quality Assessment Schemes, and operates a schedule of internal quality audit, corrective action and quality improvement.

The laboratories are recognised for training by the Health and Care Professions Council, the Royal College of Pathologists, the Association for Clinical Biochemistry and the Institute of Biomedical Sciences.

All work is performed with due care for the health and safety of staff and patients and with proper regard for the environment. The laboratories comply with comprehensive safety procedures and Control of Substances Hazardous to Health (COSHH) regulations.

User Satisfaction

As part of our quality management system and to ensure that we are meeting the needs of our users, we are always keen to receive any comments you may have regarding the quality of the service we provide and would welcome any suggestions on ways in which we might be able to improve the service. We also take complaints about our work, staff and levels of service very seriously. If you are not satisfied, please contact the Quality Manager to register a complaint. Details of the complaints procedure will be given to you at this time.

Please feel free to email any of the Quality Team with any suggestions or feedback to This email address is being protected from spambots. You need JavaScript enabled to view it. or the individual department representatives.