Standardisation and Innovation in Clinical Laboratories: Striking the Balance

Clinical laboratories are considered the beating heart of a hospital with the aim of supporting an accurate diagnosis as soon as possible. Seventy percent of the diagnosis of a patient are made using laboratory results¹, but unfortunately a considerable number of all adverse events in the hospital can be traced back to diagnostic error. ^2,3,4,5

Hospital laboratories face a very diverse set of challenges. Not only is there the pressure to get diagnostics results to be reported in a fast and correct manner, but also the increase in samples to be analysed, staff shortages and cost reductions mean that laboratories must fine-tune their processes as much as possible to deliver timely and quality results.

In this dynamic environment, two critical forces shape the landscape: Standardisation and innovation.

Standardisation: The Foundation of Consistency

Standardisation involves creating uniform processes, protocols within and across laboratory sites.

It ensures that diagnostic testing is performed in a consistent manner, regardless of location or personnel.
Several aspects are involved in Standardisation:

• Quality Assurance: minimises errors and ensure the generation of reliable and accurate diagnostics results
• Interoperability: results generated are independent of the person who performs the diagnostics test. Written procedures are examples of this 
• Efficiency: Streamlined workflows enhances laboratory staff time, reduce waste and increase productivity with reduced turn around time to get the correct results reported to the clinicians

Implementation of the IVDR regulation⁶ and standards like ISO 15189:2022 supports a clinical flow cytometry workflow where automation, standardisation and quality play a key role.

Innovation: The Catalyst for Progress

Innovation in healthcare can be considered an important factor to drive efficiency and patient care.⁷ Specifically for a clinical laboratory setting, we can rely on innovation to introduce novel tests with higher sensitivity and specificity. But also, innovation in automation, which reduce manual errors, and in data analytics through innovative software implementation to study complex clinical data and LIS connectivity can benefit clinical labs.

Implementing innovation also comes with some challenges. The investment must be made in terms of equipment, maintenance, implementing of new processes and training of personnel. The navigation between innovation and compliance with rules and regulations that labs need to adhere to, poses also some validation requirements for novel diagnostic testing or procedures.

The Dance Between Standardisation and Innovation

Standardisation and Innovation can go hand in hand.

Harmonizing existing practices while embracing new technologies, in combination with continuous improvement can bring more Standardisation in clinical laboratory workflows, while innovation can boost productivity. Embracing and implementing Standardisation and Innovation can result in more reliable and accurate clinical results that will benefit patient care. From a cost perspective, a well-balanced approach may reduce unnecessary expenses and optimal usage of staff.

BD offers an extensive portfolio of cutting-edge CE-IVD solutions that help clinical laboratories to standardise workflows and assays while adhering to regulations and be future proof through innovative products.

Find out more: Flow Foward Integrated Clinical Solutions