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Clinical Biochemistry

The Department Of Biochemistry

UKAS Accreditation Scope

Introduction

Clinical Biochemistry is a UKAS accredited clinical laboratory service that uses biochemical analysis to provide results used for the diagnosis and monitoring of disease. The laboratory is automated for the majority of tests but some testing requires more complex apparatus and manual techniques.

The Department actively promotes and supports Point-of-Care Testing (POCT) managing blood gas analysers across multiple hospital sites, blood glucose, ketone and INR testing meters and provides an on-site laboratory service in the Diabetes Centre.

The Department provides a comprehensive clinical biochemistry service to the Trust. In addition, a full service is provided to the South Birmingham community Trust, the Royal Orthopaedic Hospital and GP practices. The Department also provides specialist services including endocrinology to other hospitals in Birmingham, the West Midlands Region, the rest of the UK and the Republic of Ireland.

The Department provides a clinical advisory service, which includes the clinical interpretation of results, advice on the appropriate selection of laboratory tests and investigation and monitoring strategies for individual patients and for specific diseases. There is close liaison with clinicians and other healthcare personnel within the Trust, the Community and in other hospitals to ensure best practice in the use of the Clinical Biochemistry Service, for clinical governance and clinical audit purposes and ensure that the Clinical Biochemistry Service is an integrated component of patient care pathways.

This section outlines the use of the laboratory and many of the tests available. It is not completely comprehensive and advice should be sought if there are queries, from the Duty Biochemist within hours or the consultant on-call rota out-of-hours (contact the on-call Biomedical Scientist first).

Opening Hours

Urgent Samples

Specimens requiring immediate attention on receipt should be identified by obtaining an urgent number from extension 15985. Only specimens requiring urgent analysis where there is a need for clinical management decisions that can only be taken by biochemical investigation should use this service. Many of the urgent management decisions can be taken using results supplied by the Point-of-Care instruments available in the emergency department and intensive care units.

Prior to sending any urgent specimens, you must telephone the laboratory before dispatch of the specimen so that you can be given an urgent specimen identification number. This urgent specimen number must be noted in the designated box on the request form to provide easy identification for the laboratory staff on arrival within the department, as must the correct location of the patient. This will facilitate its processing and ensure that the results are returned directly to the requesting source. It is important to do this in order that we identify urgent specimens amongst the 4,000 requests we receive daily. You must do this at any time of day or night in order to facilitate fast processing.

The following wards are seen as priority locations:

Ward Turnaround time (from receipt of specimen)


ED, CDU, WACT, WACB, WACE, W620 


1 hour
WCCA, WCCB, WCCC, WCCD, WADM, WAMB, WBU, Oncology, W622, QCHEMO (Biochem only), QCCU, QSSU, ROTX, St Mary’s Hospice and GP samples marked urgent. 

2 hours

Please note that at times of high demand or if there are instrument malfunctions we may not be able to achieve this turnaround time.

Arrangements for urgent endocrine tests, e.g. neonatal 17-hydroxyprogesterone, should be made via the Duty Biochemist on extension 16543 during normal working hours.

For pregnancy testing, a urine test is the first line investigation and will normally be done as a Point-of-Care Test (POCT) in accordance with Trust policy. The Microbiology Department is able to offer this test during normal laboratory hours, if POCT is not available. For a patient with suspected ectopic pregnancy who is being/has been referred, Birmingham Women’s Hospital have a restricted service for serum hCG on weekend early mornings but do not have an out-of-hours service. Any arrangements for a serum hCG in this situation will be made by Birmingham Women’s Hospital clinical staff.

Samples sent for serum hCG in QEH will be assumed to be for cancer monitoring as the hCG assay is not validated for pregnancy testing and we have no reference intervals for any of the trimesters of pregnancy.

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Common Factors Affecting Analysis

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.

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Therapeutic Drug Monitoring (TDM)

A TDM service is provided in the department of Clinical Biochemistry for some of the drugs requiring regular monitoring. Please check the time at which a sample should be collected as failure to collect the blood at the appropriate time will make it impossible to compare the measured concentration with an accepted therapeutic range. Assays are of little use under these conditions.

The monitoring of valproic acid is not recommended because of the poor correlation between plasma levels and therapeutic effect. The duty biochemist must be contacted to discuss its measurement for any other purpose.

Any request for urgent therapeutic drug analysis that is not provided by Clinical Biochemistry must be discussed with the Duty Biochemist, or when out-of-hours with the duty Biomedical Scientist who may ask you to discuss this with the Duty Consultant. In some circumstances additional discussion with a pharmacist is required. Some specimens requiring analysis out-of-hours may need to be sent to the Toxicology unit at City Hospital and if you organise this without consulting the Pharmacy department you will incur charges to the trust that will not be the responsibility of Clinical Biochemistry.

Overdoses/Drug Screens

Samples for a 'Drug Screen' are analysed at the Regional Toxicology Laboratory (RTL) at City Hospital. A request for a "drug screen" or ‘unknown drug’ requires:-

  • At least 10 mL of urine in plain tube (NOT containing boric acid).  A green top (Lithium heparin anticoagulant) tube filled with blood.  Detailed patient information.
  • Clinical condition e.g. coma grade, fitting etc.
  • Current known prescribed drugs.
  • Overdose drug(s) if known.
  • Urine specimen type e.g. voided or catheter.

Blood samples taken for a ‘Drug Screen’ are of little use unless there is prior knowledge of the agent ingested. Discuss whether a blood sample is of use with the duty biochemist or duty consultant (via the out-of-hours Biomedical Scientist). Paracetamol, salicylate and lithium measurements are available on a 24 hr basis. All requests for other ingested drugs must be discussed with the Poisons Unit and Regional Toxicology Laboratory and samples sent only by prior arrangement. Any samples requiring urgent analysis at the Regional Toxicology Laboratory will require direct dispatch to that laboratory and must not be sent to the Clinical Biochemistry department. Charges realised by these analysis will be forwarded to the relevant division.

Antibiotics

Amikacin, gentamycin, tobramycin and vancomycin are measured in Clinical Biochemistry but clinical advice is given from Microbiology. For patients with liver or renal impairment, advice on antibiotic dosage is available from Clinical Microbiology.

Assays for other antimicrobials including flucytosine, teicoplanin and streptomycin are available from Microbiology after prior consultation with the Clinical Microbiologist.

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Point-of-Care Testing (POCT or Near Patient Testing, NPT)

The use of all point-of-care devices from simple dip-stick tests to blood gas analysis machines is governed by a comprehensive Trust policy and procedure. Please ensure that you are aware of the requirements of this policy before you embark on point-of-care testing. The POCT services managed by the team are rapidly expanding and include:

Blood Glucose Meters

Ward based glucose meters that measure blood glucose using a 'dry-chemistry' stick are used throughout the Trust. These meters must only be used by authorised staff that have received training via the scheme organised in conjunction with the meter manufacturer.

The working range of all glucose meters is limited and for accurate determination at the extremes of the range (2.5 - 20.0 mmol/L for the UHB meters), blood should be taken into a grey-top vacuette tube and sent to the laboratory. If the result is unexpected, send a sample to the laboratory or a sample can be processed on one of the blood gas analysers located throughout the Trust.

In hypoglycaemia, values below the working range must be confirmed by a laboratory glucose measurement. Consult the biochemist/consultant on duty prior to taking the blood so that appropriate samples can be collected for the investigation of insulinoma, should this be warranted.

Blood Gas Analysers (QEHB, Heritage Building, ROH, Moseley Hall)

The department has rationalised blood gas instrumentation in the Trust and identical instruments are sited throughout the Trust. All analysers measure pH, pCO2, pO2, sodium, potassium and ionised calcium. They provide full co-oximetry and derive values for base excess and bicarbonate. Glucose and lactate measurement is available on both sites, but not on all analysers.

The blood gas analysers are located throughout QEHB, Heritage Building and the POCT team also manage analysers at the Royal Orthopaedic Hospital and Moseley Hall Hospital.

Ward based operators and doctors are trained by staff of the POCT team. The laboratories do not have blood-gas analysers in the department and there is no in-house lactate measurement.

INR Measurement

Throughout the Trust the POCT team manage the INR devices used for rapid testing. These meters have been installed in areas where a clinical need has been identified and approved. Operators are trained by the members of the POCT team.

Ketone Measurement

To comply with the DKA guidelines and to support the diagnosis and management of patients with DKA the POCT team manage the ketone meter service within the Trust. Meters have been installed in areas where a clinical need has been identified and approved. Training and full service report is provided by the POCT team.

Other POCT Services

As well as these tests the POCT team are currently managing or are reviewing the following services:

DDimer testing, urine analysis including hCG testing (pregnancy testing) and dipsticks for screening, Haemostasis testing (ACT, APTT, ROTEM, TEG), Haematology clinics, Biochemistry one stop clinics and sexual Health testing.

If any clinical areas require advice or guidance on the installation or use of POCT systems please contact us to discuss further.

The POCT team can be contacted by: Telephone – extension 15976
Bleep - 1189
Email - This email address is being protected from spambots. You need JavaScript enabled to view it.

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Diagnosis of Diabetes Mellitus

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.

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