Patient-Centered Laboratory Medicine

At a Glance

• Laboratory medicine accounts for the highest volume of tasks conducted in a healthcare setting
• Evidence to support the contribution of the laboratory to the overall clinical process has, however, been difficult to obtain
• A task force set up by IFCC has recently published evidence supporting the impact of lab medicine in healthcare and highlighting gaps in understanding and deficiencies in use of lab tests
• A poster has been developed that provides a schematic of the opportunities for clinical laboratories to have a direct impact on clinical care and improve patient outcomes

Laboratory testing is the single highest volume medical activity, and is essential for fast, accurate diagnosis of a vast array of clinical conditions. It is recognized as fundamental to clinically cost-effective delivery of healthcare, since it is so often the principal basis for costly downstream care – admission to hospital or high-cost investigative procedures, such as biopsy or complex imaging. Laboratory medicine also has a massive impact upstream of diagnosis, playing a key role in screening and risk assessment; areas which are becoming increasingly important with the recognition that early diagnosis and intervention reduce overall healthcare costs for a wide range of common diseases.

However, systematic evidence of the contribution of laboratory medicine to the clinical process has been difficult to obtain in the past – understandable, given the range of factors involved in reaching a diagnosis or planning treatment for an individual. The need for more specific and evidence-based measures of the added value that laboratory medicine brings has been recognized for many years, and the IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) task force on the impact of laboratory medicine on clinical management and outcomes was established in 2012 to evaluate the available evidence supporting the impact of laboratory medicine in healthcare, and to develop new and prospective studies to demonstrate the contribution made by laboratory medicine to improving outcomes (1).

The task force has now published its report (2), which summarizes the existing evidence and indicates the gaps in our understanding. It also identifies deficiencies in the ways in which laboratory tests are used, suggests some potential solutions and offers a vision of a future in which laboratory medicine is used optimally to support patient care. As part of that vision, we have collaborated with The Pathologist to produce the infographic poster (see page 35 to find out how to get your copy). This presents in schematic form the multiple opportunities for clinical laboratories to have a direct impact on clinical care and improve clinical outcomes. The issues are also explored in a special issue of the eJIFCC published earlier this year (3).

Rapid, accurate diagnosis of the patient’s condition is essential to obtaining the presenting condition, and there has been much emphasis in recent years on reducing misdiagnosis, underdiagnosis and overdiagnosis. When diagnostic error arises from laboratory testing, the pre- and post-analytical phases are much more vulnerable to error than the actual analysis, where laboratory workers have traditionally focused their error-reduction strategies. Epner et al. (4) have classified the laboratory-related causes of diagnostic error as:

• ordering the wrong test
• not ordering the right test
• misapplying the test result due to misinterpretation or failure of synthesis
• missing the test result – not getting it to the right place at the right time
• test result inaccurate.

The last of these causes is the least frequent and has least impact on patient outcome (5). The poster sets out the importance of influencing test requesting and ensuring correct interpretation and follow-up of critical or significant results, while still ensuring high analytical quality and reducing misleading results caused by poor specimen collection or handling.

Laboratories also have a vital role in producing the evidence base that informs proper test utilization, which means ensuring that evaluations of biomarkers focus not just on analytical performance or diagnostic efficacy but on clinical effectiveness – a measurable impact on defined outcomes brought about by using the test (6). It is also crucial that these studies are continued as biomarkers come into clinical use, to ensure that the expected benefits are delivered in practice. This means effective participation in clinical audits – the equivalent of post-marketing surveillance in the drug field.

Laboratory doctors and scientists of the future must get out of their laboratories and become involved in the whole spectrum of clinical activity, including:

• producing guidelines for investigation
• advising clinicians on the best strategy for individual clinical presentations and the further tests needed to confirm a diagnosis
• ensuring that results are not misinterpreted or missed
• participating in audit of the effectiveness of testing strategies and using the resources of the service (human, technical and financial) effectively to do the right test on the right person in the right place at the right time.

It represents a considerable challenge, but the rewards are immense: better patient care, lower healthcare costs, improved job satisfaction for laboratory workers and enhanced ability to recruit and retain good scientists and pathologists. We hope that the new poster will help laboratory workers to better understand their role in the process, and to demonstrate the value of laboratory medicine to clinical staff, administrators, policymakers and patients.

Mike Hallworth is Chair, IFCC task force on the impact of laboratory medicine on clinical management and outcomes.

To obtain a free copy of the poster discussed in this article, please visit the IFCC booth at Euromedlab Paris 2015, 21-25 June, or email [email protected]