Diagnostics

Laboratory medicine: over a billion tests, but limited clinical value

The Electronic Health Record 2.0 can make data more measurable, moving from the medical report as a document to the result as structured clinical data

Researcher working with microplate panel for diseases diagnosis in the laboratory. Doctor working with microplate for elisa analysis angellodeco - stock.adobe.com

4' min read

Translated by AI
Versione italiana

4' min read

Translated by AI
Versione italiana

Over 1.13 billion laboratory tests were recorded in 2023, averaging around 19 per inhabitant. This is a huge figure, yet we do not have a unified national overview of the overall costs of diagnostics nor, above all, of its impact on care pathways. It is this gap between volume and value that the National Health Service must learn to bridge.

The Electronic Health Record 2.0 (EHR 2.0) could prove to be a decisive factor. The National Recovery and Resilience Plan (PNRR) has allocated approximately 1.3 billion euros to its development, and the Ministry of Health has stated that, by June 2026, it will have achieved the target of producing at least 90 per cent of the documents covered by the indicator – including laboratory reports – directly in electronic format. However, a digital report does not, in itself, guarantee that individual results are standardised, interpretable and comparable across different laboratories.

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Prevention and diagnosis

Laboratory medicine supports individuals throughout their entire lives: it identifies biomarkers for prevention and diagnosis, guides treatment and monitors the response to it. However, its value is not limited to the measurement of individual parameters: it also lies in the ability to correlate different results, track their progression over time and interpret them within a clinical context.

The available figures tell only part of the story. Ministerial surveys do not take into account the work carried out in A&E departments, in the private healthcare sector and in decentralised diagnostic services. Added to this incompleteness is the time lag: we are still using data from 2023 to describe national activity. Furthermore, from an economic perspective, there is no single, consolidated figure that identifies the full cost of laboratory medicine across the various healthcare settings. Fees, recorded expenditure and the actual cost of production measure different phenomena.

For too long, laboratory diagnostics have been assessed primarily in terms of volume, fees and the cost per test: these are necessary indicators, but they are insufficient. Value emerges when timely and reliable information improves diagnosis, prevents inappropriate treatments, guides therapy, reduces complications or hospital admissions, and enhances clinical monitoring. This is the approach of Value-Based Laboratory Medicine: evaluating tests not only on the basis of their cost, but also in terms of the clinical benefits they help to deliver.

Digital documents

FSE 2.0 can make this value more measurable, moving from the report as a document to the result as structured clinical data. A person with diabetes or chronic kidney disease may be monitored for years, changing doctors, laboratories or regions over time. If the results remain confined to unstructured digital documents such as PDFs, with different names, units of measurement or reference ranges, comparing them over time is difficult and can lead to errors. If, on the other hand, the data retains its clinical identity and context, it can support more informed decisions and limit unnecessary repetition.

This is why we need structured, coded and interoperable data. LOINC is the international standard that identifies types of tests or clinical observations; however, the choice of codes must be guided and harmonised. But the code alone is not enough: units of measurement, methods, reference ranges and interpretative information are also important. It is also necessary to harmonise the content, language and presentation of test reports to make them comparable and comprehensible. Digitisation, therefore, must not result in the loss of the data’s informational and clinical value, but must ensure its correct interpretation and full utilisation, even in different contexts over time.

This is where laboratory medicine professionals come into their own. The correct interpretation of data is not merely a computer-based task. These professionals ensure analytical quality, appropriate reporting and correct coding, thereby contributing to the management of results and collaboration with other healthcare professionals.

The SIBioC Conference

A SIBioC exploratory survey of 254 professionals, presented at the 2026 National Congress, highlights that the harmonisation of results remains limited: only 40 per cent report at least partial adoption of LOINC, whilst 45 per cent report coordinated regional projects or initiatives. Whilst this is not a representative sample of the whole country, it indicates that the transition is still proceeding at varying speeds.

A national implementation plan is therefore needed to train professionals and provide a shared, up-to-date tool, based on validated criteria, to guide the correct and harmonised assignment of LOINC codes, accompanied by a monitoring system and outcome indicators. And we need a programme capable of measuring the value of laboratory medicine in high-impact clinical pathways — diabetes, chronic kidney disease, oncology, and emergency and urgent care — by linking tests, decision-making times, treatment appropriateness, outcomes and costs.

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Sustainability is not achieved by indiscriminately cutting the cost of individual tests. It is built by measuring the clinical and economic value of diagnostic information. This is the challenge: moving from the test result to the data, from the data to information, and from information to clinical decision-making.

*President of SIBioC

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