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Introduction

Copyright UHB Pathology 2018

Protection of Personal Information – Pathology Laboratories Services comply with the Trust Data Protection Policy and have procedures in place to allow the Directorate and it’s employees to comply with the Data Protection Act 1998 and associated best practice and guidance.

The laboratories at Queen Elizabeth Hospital, Heartlands Hospital, Good Hope Hospital and Solihull Hospital form part of the services provided by University Hospitals Birmingham and are UKAS (United Kingdom Accreditation Service) accredited to the ISO 15189:2012 standard.  Laboratories are currently transitioning across to ISO 15189:2022 standard. For a list of accredited tests and other information please visit the UKAS website using the following link: https://www.ukas.com/find-an-organisation/

  • Molecular Pathology is a UKAS accredited medical laboratory No. 8759
  • Biochemistry is a UKAS accredited medical laboratory No. 8910
  • Haematology and Transfusion is a UKAS accredited medical laboratory No. 8784
  • Clinical Microbiology is a UKAS accredited medical laboratory No. 8760
  • Cellular Pathology is a UKAS accredited medical laboratory No. 10141
  • Musculoskeletal laboratory is a UKAS accredited medical laboratory No. 9897
  • United Kingdom Health Security Agency laboratory is a UKAS accredited medical laboratory No.8213

Tests not appearing on the UKAS Schedule of Accreditation currently remain outside of our scope of accreditation. However, these tests have been validated to the same high standard as accredited tests and are performed by the same trained and competent staff.

For further test information, please visit the test database: http://www.heftpathology.com/frontpage/test-database.html.

For further information contact Louise Fallon, Quality Manager, 0121 371 5962/ 0121 424 1235

 

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Edoxaban Assay

Edoxaban is one of the direct oral anticoagulants, exerting an anticoagulant effect by inhibiting activated factor X.

Changes in the prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) may be observed in patients on therapeutic edoxaban doses. However, these changes tend to be small, unpredictable, and highly variable, so clinicians should not use these markers to monitor the anticoagulant effects or titrate the dose of edoxaban (Plitt A, Giugliano RP. Edoxaban: review of Pharmacology and key phase I to III clinical trials. J Cardiovasc Pharmacol Ther. 2014;19(5):409–416).

Urgent requests should be discussed with the laboratory prior to receiving the sample.

This test will be reviewed by UKAS for ISO 15189 accreditation at the next surveillance visit in October 2019

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Clinical Decision Limits

Phoning limits for biochemistry tests are as follows:

Decision limits for phoning

Analyte

Phone results below or equal to:

Phone results above or equal to:

Units

Notes

Sodium

120

150

mmol/L

 

Potassium

2.5

6.5

mmol/L

 

Urea

-

Adults: 30

Paediatrics: 10

mmol/L

Except those on renal wards or under renal consultants.

Creatinine

-

Paediatrics: 200

umol/L

eGFR

Adults: 15

-

ml/min

AKI

-

2

 

Not CKD patients (AKI 2 discretionary)

Glucose

2.5

25

mmol/L

 

Calcium adjusted

1.8

3.5

mmol/L

 

Magnesium

0.4

-

mmol/L

 

Phosphate

0.3

-

mmol/L

 

AST

-

600

U/L

 

ALT

-

600

U/L

 

Total CK

-

5000

U/L

 

Amylase

-

500

U/L

 

Digoxin

-

2.5

ng/mL

 

Theophylline

-

25

mg/L

 

Phenytoin

-

25

mg/L

 

Lithium

-

1.5

mmol/L

 

Troponin T

-

GP only: >14

ng/L

GP only

Ammonia

-

100

umol/L

 

Ethanol

-

Paediatrics only: any detectable

mg/L

Paediatrics only

Paracetamol

-

10

mg/L

Not ED patients

Salicylate

-

300

mg/L

Not ED patients

Conj bilirubin (DBIL)

-

Paediatrics only:

25

umol/L

Paediatrics only

Total bilirubin

-

Paediatrics only: 225

umol/L

Paediatrics only

Carbamazepine

-

25

ug /mL

 

Iron

-

ED only: 70

umol/L

ED only

Phenobarbitone

-

70

mg/L

 

CSF Gluc

3.3

-

mmol/L

 

CSF Prot

-

0.45

g/L

 

Lactate

-

2.3

   

CRP

-

300

   

Total bile acids

-

20

   

Methotrexate

Phone all

umol/L

 

 

Immunology results to be telephoned:

  • CD4 count <200 cells/cumm or <10% on new patients (paediatric levels are different, but agreed with Paed consultants)
  • Lymphocyte subsets in infants <2yo: Any T cell subset below age-related normal range, any other abnormality suggesting SCID (e.g. MHC class II deficiency). (Note this is not exclusive: any abnormality may be discussed with requesting clinician)
  • New positive GBM antibodiest
  • New positive MPO antibodies
  • New positive PR3 antibodies
  • New paraprotein IgG , A or M  > 20g/L
    • IgD or IgE (any size)
    • serum monoclonal free light chains (any size, whether or not with intact paraprotein)

Abnormal Laboratory Test Results – Triggers for Telephoning Results Haematology

HaemoglobinWhite Blood Cell Count
<8.0 g/dl normochromic and normocytic Low result – neutropenia <0.5 x 10 9/L
<7.0 g/dl microcytic and hypochromic   High result – White cell count >40 x 10 9/L
<7.0 g/dl macrocytic  or Lymph count > 20 x 10 9/L
<5.0 g/dl renal patients Any presence of blast cells
PlateletsClotting Studies
Lower limit - <70 x 10 9/L   INR - >5.0
Upper limit - >1000 x 10 9/L   PTT - >180 seconds
  Fibrinogen < 1.0g/l
  • All Positive Malaria Screens
  • All Anti FXa results >1.20 iu/ml
  • If the patient is known to the department and has had a similar result within the previous 7 days then the urgent contact is not necessary.

HPA Microbiology – List of abnormal results telephoned to clinical staff

Bacteriology

  • Gram stain results of positive blood culture on Day 1
  • Positive CSF results
  • Positive sterile site results
  • Significant in-patient results from enteric bench
  • Multi resistant gram negative and gram positive isolates including mupirocin resistant MRSA
  • Group B streptococcal isolates from neonates
  • Group A in patient isolates
  • Positive Legionella urinary antigen and Pneumococcal urine antigen results
  • Smear and culture positive Mycobacteria
  • Antibiotic assay results outside normal ranges
  • Any other significant results at the discretion of Medical Microbiologists

Virology

  • Serological evidence of acute infection with Hep A, Hep B and in pregnant patients CMV, Parvovirus and Rubella
  • New diagnoses of HIV
  • VZV IgG negative from exposed patients at risk of severe VZV infection
  • New diagnosis of Hep B, Hep C and HIV in haemodialysis patients
  • Evidence of Hep B/Hep C and HIV in needle stick injury source patients
  • Clinically important positive respiratory PCR results i.e.: influenza, RSV in immunocompromised patients
  • Positive PCR results in outbreaks
  • Positive blood PCR for CMV and Adenovirus
  • Negative blood results for CMV PCR
  • Significant blood PCR results for EBV and Polyomavirus
  • All positive PCR results on CSF specimens
  • All positive Chlamydia PCR results on eye swabs
  • All positive PCR results from neonatal unit
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Haematinic Guidelines

HEFT Pathology Guideline Investigation and Referral Pathways for Anaemia in Primary Care

Produced by:

Dr Sukhbir Kaur (Senior Clinical Biochemist)

Approved by:

Dr Kartsios Charalampos (Consultant Haematologist)

 

Dr Marcus Mottershead (Consultant Gastroenterology)

This guidence covers the following areas

1. Anaemia Testing in Adults

2. Iron Deficiency Anaemia Testing in Adults

3. Iron Deficiency Anaemia Treatment and Monitoring Advice

4. Vitamin B12 Deficiency Testing, Treatment and Monitoring

5. Folate Deficiency Testing, Treatment and Monitoring Advice

6. Renal Anaemia Testing in Adults

biochemistry, haematology, haemainics

Read more: Haematinic Guidelines

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Tumour Marker Use in Primary Care

In the last 5 years requests for tumour marker tests from Primary Care have more than doubled. This high use in Primary Care is worrying because the majority of tumour markers (eg. CEA, CA19-9) are neither specific nor sensitive enough for use in the diagnosis of malignancy. See this link for a summary of the main tumour markers, their uses and limitations.

The main use for tumour markers is in monitoring disease progression, treatment or recurrence of a histologically diagnosed cancer. A recent audit of Primary Care requests for tumour markers found that only 9% of CEA and 4% of CA19-9 were requested for these reasons; the rest being for non-specific symptoms.

In contrast to the above, CA125 and PSA do have use in diagnosis of their related cancers, however it should also be noted that these are still only a diagnostic aid and should be used with caution as both can be raised in a number of other benign conditions (see table). Please click the relevant links below of links to guidelines relating to their use in Primary Care.

CA125 link https://pathways.nice.org.uk/pathways/ovarian-cancer

PSA link https://www.gov.uk/guidance/prostate-cancer-risk-management-programme-overview

For symptoms and referral guidelines of other malignancies see the NICE Suspected Cancer Recognition and Referral guidelines. http://pathways.nice.org.uk/pathways/suspected-cancer-recognition-and-referral

You can also use the search bar or test database on this website to find more specific information on the use of each tumour marker.

Tumour marker

Main application

Other tumour elevations

Other limitations

CEA

Monitoring colorectal adenocarcinomas

Breast, lung, gastric, mesotheliomas, oesophageal and pancreatic

Raised in smokers

Raised in other benign renal, liver, lung or GI disease

Poor sensitivity in early disease and may be absent/low in poorly differentiated tumours

CA19-9

Monitoring pancreatic carcinoma

 

Raised in obstructive jaundice, cholestasis, cirrhosis, pancreatic hepatitis and non-malignant GI disease.

Not present in those negative for the Lewis blood group determinant.

CA125

Monitoring ovarian carcinoma

 

Raised in patients with ascites, pleural effusions or free fluid in the pelvis

Raised in patients with congestive heart failure

Raised in benign renal and liver disease and other adenocarcinomas

Mildly raised in menstruation and the first two trimesters of pregnancy

Can be raised in endometriosis

CA15-3

Monitoring breast cancer

Lung, colon, ovary

Raised in benign liver, breast, ovarian disease

AFP

Diagnosis and monitoring of hepatocellular carcinoma and germ cell tumours

Gastric and other GI (oesophageal, pancreatic)

Raised in pregnancy and neonates

Raised in benign liver disease

PSA

Diagnosis and monitoring of prostate carcinoma

 

Also elevated in benign prostatic conditions

Increases with age (as prostate size increases)

Elevated in UTI, catheterisation, prostatitis or other prostate manipulation

hCG

Diagnosis and monitoring of germ cell tumours and gestational trophoblastic neoplasia

Lung

Raised in pregnancy

Transiently elevated with cannabis use

LDH

Diagnosis and monitoring of germ cell tumours

 

Elevated in cardiac disease and benign liver disease

Elevated in some anaemias relating to non-malignant disease

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