Monoclonal Gammopathy

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Monoclonal gammopathy lab
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tool
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Dr Ross Sadler PhD FRCPath
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Consultant Scientist
Oxford University Hospitals Foundation NHS Trust
Myeloma UK Laboratory Best Practice Committee
Monoclonal gammopathy lab tool
What are the stages of Monoclonal gammopathy care?
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Patient and Primary care
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Issues highlighted and
suitable differentials
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initiated
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First symptoms First
presentation
to GP clinic
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Patient and Primary care Laboratory
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Issues highlighted and Patient investigation
suitable differentials and stratification
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initiated
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First symptoms First Early blood Secondary Referral to
presentation markers care specialist
to GP clinic diagnosis
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Patient and Primary care Laboratory Clinical Haematology
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Issues highlighted and Patient investigation Patient investigation,
suitable differentials and stratification stratification and
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initiated management
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First symptoms First Early blood Secondary Referral to Haematology Treatment
presentation markers care specialist review
to GP clinic diagnosis
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Patient and Primary care A guide for GPs on when to refer and
how urgently
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Issues highlighted and Shared via Macmillan GP network
suitable differentials
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and others
initiated Article that centres around the tool
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published
by RCGP journal InnovAiT
Aim to get the tool embedded into
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presentation
to GP clinic
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Patient and Primary care 94% of GPs felt more
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confident recognising
Issues highlighted and the signs of myeloma
suitable differentials thanks to our
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GP Diagnostic Tool
initiated
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87% of GPs felt more
confident interpreting
the results of tests for
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our GP Diagnostic Tool
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presentation
to GP clinic
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Laboratory
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Patient investigation
and stratification
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Early blood Secondary Referral to
markers care specialist
diagnosis
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Laboratory Laboratory flagging of abnormal results –
NEQAS audit
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Patient investigation
and stratification
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Total
Comment reported Yes No responses
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Paraprotein concentration 92% 8% 86
Possible underlying condition 27% 73% 79
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(if not done) – Urine
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Early blood Secondary Referral to Recommendation of further testing 59% 41% 82
markers care specialist (if not done) – SFLC
diagnosis
Repeat testing time interval 55% 45% 85
Recommend referral to haematology 46% 54% 83
>75,000 individuals screened, with 3,725 monoclonal gammopathies identified
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Patients followed up long term.
Initial findings reported early 2022 on 3 years follow up.
>75,000 individuals screened, with 3,725 monoclonal gammopathies identified
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Patients followed up long term.
Initial findings reported early 2022 on 3 years follow up.
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Are you
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A testing service?
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OR
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A Healthcare Laboratory Service?
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Generating accurate data on a sample is the bare minimum to be
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done. Understanding and contributing to the next steps of care management for a
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patient, based on those results and known factors is as important as generating the
data in the first place.
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Audit questionnaire work in 2017 highlighted that particular laboratory
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processes that would be considered best practice were being performed
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approximately in 50% of labs nationally
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A second national audit performed in 2019, focusing on immunoglobulin
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testing practice across different laboratories showed that additional
concerning process.
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32 centres contributed to the audit, with 30/32 centres giving 100 samples
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requesting immunoglobulins. These were comprised of 4 x 25 consecutive
samples.
Total of 3140 samples
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53.5% female, 46.5% male
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Age range of patients = 0-99 years, median 65 years
Coeliac
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? 1.6%
investigations 2.5%
1014 from primary care
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Othr
5.7 % Myeloma 654 haem
Rheum
screen 273 outpatient
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6.7 %
24.3 % 180 inpatient
Liver 113 external
8.6 % O 54 Paeds
Immunodeficiency 50 Imm
No Clinical details
9.1 %
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22.4 %
Known LPD 2.1% of all samples had been tested for immunoglobulins in the
19.0 %
last 13 days.
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Coeliac Myeloma screening
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? 1.6%
investigations 2.5% 8.6% (66) of samples did not have an
Age range 22-99 electrophoresis run alongside the
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Othr
5.7 % Median 69 immunoglobulins
Myeloma
Rheum
screen Coded from clinical details 1.3% (10) of the samples did not
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6.7 %
24.3 % stating: have immunoglobulins run alongside
Liver Myeloma screen the electrophoresis
8.6 % O Raised Ca 5.5% (42) of the samples showed IgG
Immunodeficiency Cytopaenia
No Clinical details levels of <6g, 8 of these samples did
9.1 % Renal impairment
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22.4 % not have electrophoresis run
Known LPD Bone pain/trauma/back pain
19.0 % Neuropathy 4.5% of samples had already had
Weight loss immunoglobulins measured in the
Fatigue past 6 weeks
pruritis
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Coeliac No clinical details
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? 1.6%
investigations 2.5%
Total of 703 samples had no clinical details, defined as either
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Othr
5.7 % Myeloma
completely nothing stated (578) or with illegible/uninformative
Rheum details (e.g. ‘routine’)
screen
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6.7 %
24.3 %
Liver 32.6% samples come from primary care
8.6 % O
Immunodeficiency
14.8% samples come from haematology
No Clinical details
9.1 %
2.3% samples come from acute medicine
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22.4 %
Known LPD
19.0 % 13.2% did not have electrophoresis run with 14 samples showing
IgG levels <6g/L, 1 patient showed IgA 12.6g/L
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June 2017
Coeliac
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? 1.6%
investigations 2.5%
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Othr
5.7 % Myeloma
Rheum
screen
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6.7 %
24.3 %
Liver
8.6 % O
Immunodeficiency
No Clinical details
9.1 %
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22.4 %
Known LPD
19.0 %
What is happening now?
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1) Preliminary questionnaire of myeloma screening laboratories
Desire to understand what progress laboratories have made since 2019 in there myeloma screening service,
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despite COVID.
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What type of progress has been made – Pre-analytical, analytical, post analytical
2) Development of a monoclonal gammopathy screening best practice lab tool
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Follows the general concept and design of the GP best practice tool, with expert committee creation of specific
best-practice guidance for service delivery
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Guidance is broken down according to the 3 phases of investigation - Pre-analytical, analytical, post analytical
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Guidance is categorised into 3 separate classifications – Essential, desirable, optimal
The design of this tool has been structured to consider the pressure that laboratories are under with regards to
service change and development. Priority should be given to essential components.
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Primary recommendation
The testing laboratory must collaborate with Clinical Haematology to create joint working patient flow pathways for
new monoclonal gammopathy patients
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Version 0.2
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Version 0.2
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Version 0.2
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Version 0.2
The testing laboratory must collaborate with Clinical Haematology to create joint working patient flow pathways for new
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monoclonal gammopathy patients
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Version 0.2
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Version 0.2
We have a role that makes a difference
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Performing myeloma screens is not a straight-forward process but it is a vitally important one.
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Getting the correct tests requested, for the right reasons, and performing the subsequent investigative and
interpretative processes that are generated, are critical for efficient, high quality patient safety.
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The laboratory has always been fundamental to this care pathway – whether we like it or not.
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There is not clear evidence to justify mass screening of society for
this disease, which means that we need to be more sophisticated
than simply ‘test all’ or ‘test none’.
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The patient did not choose to have symptoms suggestive of
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monoclonal gammopathy, the laboratory is being asked to be
pivotal in ruling in or ruling out monoclonal gammopathy.
All patients who enter this investigation pathway must have a
route, no one should be left behind.
Myeloma UK Laboratory
Best Practice Committee:
Mark Drayson
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Dina Patel
Guy Pratt
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Alex Richter
Thank you Jo Sheldon
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Mary Stapleton
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Fenella Willis
Myeloma UK team:
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Tom Jennis
Ira Laketic-Ljubojevic
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Mairi Whiston
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myeloma.org.uk @myelomauk
Clinical Service Excellence Programme
Event and meeting highlights Primary care education
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Clinical Trial Finder Secondary care education
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Drug Tracker Laboratory best practice
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Myeloma Spotlight e-bulletin Nurse education
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academy.myeloma.org.uk

Monoclonal Gammopathy

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2) Development of a monoclonal gammopathy screening best practice lab tool

Thank you Jo Sheldon

Event and meeting highlights Primary care education

O Guidelines and tools

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