Workshops

Tuesday 24th April

W1

The result is +, ++, 2+, Pos, Trace, Neg, 20 mmol/L or 5 mg/dL!! Why dipstick EQA gives an insight into errors waiting to happen.

Dr Rachel Marrington, Birmingham

Urine dipsticks are widely used in laboratories and at the point-of-care within hospitals and in the community. This may not be an effective use of financial resources if dipsticks are inappropriately used, or the reporting of results and interpretation are inaccurate. Clinical decision pathways can be initiated by the result of a simple urine dipstick test, therefore errors at this point can be very costly.

This workshop will explore the problems surrounding the use and interpretation of urine dipsticks through a ‘hands-on’ practical example. Issues regarding the test itself; sample mis-reading; training and result reporting will be open for discussion within the group, supplemented with conclusions from the UK NEQAS EQA scheme for urine dipsticks.

As well as highlighting the main issues with urine dipsticks, the overall objective of this session will be to allow users, or those involved with POCT to share their experiences. It is hoped that this workshop will raise awareness, and discussions will offer possible solutions to address the control of quality of urine dipsticks within the clinical arena.

W2

Immunoassay - How low can we go?

Dr Cathie Sturgeon, Edinburgh

In the context of immunoassay, an appreciation of how to assess both "How low can we go?" and "How low should we go?" for each analyte or family of analytes measured is fundamental to provision of a high-class analytical service. While both questions are closely related, the answer to the first can be readily determined experimentally, while that to the second is likely to be influenced by clinical considerations, and is more subjective.
 
"How low can we go?" essentially refers to the lowest concentration that can be reliably distinguished from background noise. A number of terms and concepts have been used to describe this, inevitably resulting in some confusion, as recently highlighted on the ACB Mail Base. Often rather loosely referred to as sensitivity, this property of an assay has been termed the lower detection limit of the assay but is more exactly described as the ‘precision of measurement of zero dose’. Typically established by assaying replicates of a sample containing none of the relevant analyte, this is usually expressed as the concentration equivalent to the mean counts obtained from the zero sample plus 2 standard deviations for immunometric assays, and minus 2 standard deviations for competitive assays.
 
In practice, imprecision increases very rapidly at low concentrations, so it can be more helpful to define the "lowest concentration at which an assay can report clinically useful results". First described for TSH assays and termed "functional sensitivity", this was defined as the concentration at which a day-to-day CV of not more than 20% is achieved. This concept has been widely adopted for other analytes. Rigorous experimental assessment of functional sensitivity should be included in any method evaluation, and should then be regularly assessed, most readily by inclusion of Internal Quality Control specimens of appropriate concentration. External quality assessment data also provide an excellent indication both of what is achievable "in the field" for a particular method as well as an indication of what represents the current "state-of-the-art" for a given analyte.
 
"How low should we go?" or "What is the lowest concentration that should be reported?" is another interesting question that requires careful consideration of the clinical application for each analyte. In the follow-up of acromegalic patients, for example, the growth hormone concentration regarded as suggestive of residual or recurrent disease has decreased significantly in recent years, requiring improved assay performance at low concentrations. However for some other analytes (e.g. progesterone) decreasing the lowest concentration reported is unlikely to be of clinical benefit.
 
In this Workshop, how best to assess the lower detection limit and functional sensitivity of an assay ("how low we can go") will be considered, together with the what should be achievable in routine practice, and some of the issues related to deciding the lowest concentration to report ("how low we should go") will be discussed.
 
W3

What does a GP want from the lab services they commission?

Dr Nick Smith, Manchester

GP's have seen many improvements in their access to biochemistry services in the last decade. Increased range of tests, computer linking, increased interpretive advice.

What will be tomorrows challenges? Increase in Chronic Disease Monitoring, extended primary care may want faster turn around or near patient testing.In these days of van based diagnostics will the lab need to become mobile?

Will historical contracts be threatened by competition with the private sector? Do NHS providers need to add extra value to their contracts?

W4

What do Members want from the ACB?

Ms Janet Smith, Birmingham and Dr Tony Stott, Liverpool

The Association for Clinical Biochemistry is your professional organisation but what do you want it to provide for you and how can your viewpoints be made known to Council and Association officers?

How can the Association be effective in influencing decisions affecting the provision of laboratory medicine for primary, secondary and tertiary care and have effective dialogue with Strategic Health Authorities?

This workshop will provide you with the opportunity to have your say and influence Association policy. Possible topics for exploring :-

  • Two-way communication within the ACB
  • What information do you want from the ACB?
  • What is the ACB role in training in the NHS, now and in the future?
  • Is there a role for specialist sub-groups within the ACB?
  • How can the ACB represent clinical biochemistry in the political arena?
  • or is there another issue you would particularly like aired?

Participants will be given the opportunity to prioritise the agenda for the Workshop.

W5

W6

Wednesday 25th April

W7

How do we influence Government Policy?

Joe O'Meara, ACB Government Affairs Officer, London

A highly interactive session exploring ways in which the ACB might influence Government Policy in its widest sense. We will consider the challenges facing our profession and our short and long term objective to address them as well as the mechanisms that we might adopt to achieve them. The scope will encompass the important topic of public relations and the public perception of our profession as well as how we might collaborate with other organisations to further our aims.

W8

UK NEQAS for eGFR

Mr Finlay MacKenzie, Birmingham

This workshop is intended to look at the practical consequences of trying to underpin clinical findings using the results of a poorly performed test, namely creatinine, in the area of estimating glomerular filtration rates. Laboratory medicine as a whole has singularly failed to address, or if being charitable, ‘resolve’, the shortcomings of specificity and calibration in this assay over the last 20 years. Though not actively excluding delegates over the age of 35, for whom this is perhaps already a lost cause, I am intending to present this to an audience which might just take issues like this a bit more seriously in the future.

The measurement of creatinine may not be as glamorous as looking at subtleties of DNA expression, genetic mutations and the like. However, until these tests are analysed in their thousands every day by hundreds of labs across the length and breadth of the UK, then there is still relevance for tired old analytes, such as creatinine, which are.

This workshop addresses the dilemma of underpinning never-to-be-repeated rafts of clinical evidence with results from a method giving potentially the ‘wrong’ results, when there were better methods available which could have given the ‘right’ answer.

W9

The laboratory's contribution to clinical effectiveness

Andrea Rita Horvath, University of Szeged, Hungary

The effectiveness of an intervention is the degree to which the desired health outcomes are achieved in clinical practice. Clinical effectiveness is closely linked to efficacy (the degree to which the desired health outcomes are achieved in optimal circumstances), efficiency or cost-effectiveness and to the quality of service.

Outcomes are results of medical interventions in terms of health or cost. Laboratory-related outcomes can be classified as 1/ clinical (e.g. morbidity, mortality, quality of life, complication or readmission rate); 2/ operational (time to treatment, length of stay); and 3/ economical (e.g. cost/QUALY, cost/diagnosis, cost/treatment). Often laboratory tests are surrogate outcome measures themselves: HbA1c for progression of diabetes mellitus, urine albumin for renal failure, cholesterol for cardiovascular disease and mortality, BNP for heart failure, PTH for renal osteodystrophy, etc.

The workshop will discuss the questions below using several case scenarios:

  • Does or can laboratory testing improve outcomes, and thus can laboratories really contribute to clinical and cost-effectiveness?
  • What is the relationship between testing and different forms of outcomes?
  • How can we measure laboratory-related outcomes?
  • What are the key problems with measuring outcomes?
  • What studies should be designed to investigate the relationship between testing and outcomes?
  • Is clinical effectiveness related to testing perceived as improved health outcome by patients also?
  • What happens when testing causes adverse outcomes?

Participants should bring their own examples where testing clearly improved outcomes or the lab contributed to clinical effectiveness. Examples on the contrary are also welcome.

W10

USERS AND LAB STAFF: COULD PERCEPTIONS OF LAB OUTPUT DIFFER?

Dr Ceridwen Coulson, North Bristol

This session will look at our major laboratory output, reports, whether electronic or paper, from the perspective of users. For example, are patients’ results laid out as we would expect them to be, with the correct reference ranges and units? Are our comments seen and is it always clear on an electronic report that there is a comment, if one is included? Are there some test results for which we provide too much interpretation? Where do we really add value? What proportion of our reports are never seen by the requestor for a variety of reasons? Do we phone our users with those results that they do wish to know urgently? Etc…..

This interactive workshop will raise more questions than provide answers, but will allow us to think about this important area from a different point of view. This may enable us to make improvements. Participants will be asked to bring examples of good and poor communication.

W11

DEVELOPMENT OF POINT OF CARE IN THE COMMUNITY SETTING

Nicky Hollowood, Harrogate and District NHS Foundation Trust

Recent government publications outlining the future of NHS services have strongly indicated a move of expertise and laboratory testing, based in the hospital, into the community setting. It is essential that this move is fully supported by an accredited laboratory to ensure that the Medical and Healthcare Regulatory products Agency (MHRA) and Clinical Pathology Accreditation (CPA) standards are met.

At Harrogate and District Hospital the vast majority of Point of Care testing is electronically linked into the Laboratory and Hospital Information Systems to ensure a full audit trail of patient and quality control results as well as a comprehensive training programme which is co-ordinated by Biochemistry. Following the successful implementation of a networked glucose monitoring system in the hospital, this has now been extended to the community. This has enabled the laboratory to centrally co-ordinate a laboratory service which meets MHRA and CPA requirements in the community setting. The glucose testing is performed in various locations throughout Harrogate community and the results are returned electronically to a quality management programme centrally managed in Biochemistry at Harrogate Hospital. The patients results pass electronically into the Laboratory Information System and can be viewed throughout the hospital and community (ICE Results Viewer). Development work is still being undertaken to ensure that these results pass into the GP information system (EMIS).

Development of electronic links between the community and hospital has enabled point of care equipment to be implemented in the community and the service to be managed electronically from the hospital. Now the information flow has been established, an electronic platform for development of further point of care testing in the community has been provided. This has opened the door to the implementation of a wide range of quality laboratory services in the community which are centrally controlled and managed by the laboratory, delivering service criteria as outlined in Modernising Pathology Services.


W12

W13

Growth hormone standarisation - where are we?

Growth hormone (GH) measurements contribute significantly to the diagnosis and treatment of acromegaly and growth disorders and require reliable and precise analytical methods that produce results that are readily comparable between centres. Somewhat disappointingly, however, despite major advances in assay technology over the last few decades, there has been little improvement in between-laboratory agreement and results for the same EQA specimen may still differ by as much as two-fold depending on the method used.

Factors contributing to analytical discrepancies include errors of calibration and differences in antibody specificity and assay design. These cause difficulties when trying to implement guidelines and protocols that specify cut-off levels for dynamic function tests of stimulation or suppression or when comparing results of clinical studies. Additionally GH results may be reported in different units – often mass units (g/L) in the United States and arbitrary units (mU/L) in the UK – and immunoassays may be calibrated in terms of different standards.

An International GH Collaborative convened by ACB members and supported by leading clinical endocrinologists, recently developed a Consensus Statement that has now been widely adopted and publicized. It states that all GH results should be reported in terms of mass units of the new WHO rDNA-derived International Standard for GH (IS 98/574) using assays that are accurately calibrated against this Standard. This year the establishment by the IFCC of a Working Group for Growth Hormone Standardization has provided additional international support for this initiative.

The clinical and laboratory communities must now work together towards successful implementation of the proposals in the Consensus Statement. In this Workshop we will review

  1. Progress in accurately calibrating existing GH methods against IS 98/574.
  2. Clinical and laboratory implications of the change in calibration and unitage.
  3. Likely time to completion of the changeover to mass units of IS 98/574. 
  4. The role of EQA organisations during the transition. 
  5. The roles and contributions of individual stakeholders. 

Following the Workshop, a summary of progress will be provided via the UK NEQAS network, through publications in the clinical and laboratory press, and on a dedicated ACB Mail Base forum that will be established to report the Workshop outcomes, mirroring a similar forum being set up by the Society for Endocrinology. We would very much welcome your input and views before, during and/or after the Focus Workshop!! 

W14

Just the BIS Bioinformatic Scientists Training skill sets for the next generation

Dr John O'Connor, Exeter

This workshop will explore the case for pathology to manage its own informatics resources by demonstrating the magnitude of related activities that are involved across all pathology disciplines. It can be argued that we do not have sufficient number of trained personnel in order to effectively achieve this. In the UK, it is common for those responsible for managing IT systems to have been recruited from those biomedical scientists who have shown a strong interest in the field. Our IT professionals working within NHS trusts often perceive such staff as gifted amateurs. This would be an unfair criticism and the efficiency and robustness of Pathology Informatics programmes is a tribute to the hard work and energy of these dedicated staff. The projects success is further evidence of the ability of such staff to get national projects implemented. The job they do needs to be formally recognised and I propose that there should be an advanced practitioner in laboratory medicine (AP) with an Advanced Specialist Diploma; which demonstrates expertise with the field, closely associated to the Professional Doctorates. The workshop will review an embryonic syllabus for such a training programme. We will discuss the logistics of how such practitioners could be deployed in routine laboratory environments.

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