Compliance is king- pathology labs sourcing diagnostic chemicals

This article is an original article from Pathology in Practice

Laboratory professionals’ due diligence on the chemical products used in their diagnostic analysis work is increasingly vital, according to diagnostic stain and reagent manufacturer, Atom Scientific.

The change in regulations for manufacturers of in vitro diagnostic devices and materials post-Brexit means laboratories should ensure their suppliers are meeting the right quality standards.

For example, the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) already applies in Northern Ireland and affects UK products already registered with the EU IVDR.

Peter Keenan, Commercial Director at Atom Scientific, said: “Laboratories using chemical products such as stain kits for tissue analysis and diagnosis need to ensure the product is authorised for this task, as some are only deemed suitable for research purposes."

“This is vital if pathology professionals are concerned about their own compliance with quality management systems, such as ISO15189 for quality and competence in medical laboratories.”

Atom Scientific is the only UK manufacturer of diagnostic stain kits to comply with the recent EU regulation 2017/746 covering In Vitro Diagnostic Medical Devices for diagnostic use (IVDR) as well as research.

Peter Keenan added: “Our stain kits and biological stains, while retaining their CE mark outside of the UK, have also this year attained the new UKCA mark for general in vitro diagnostic (IVD) devices, which complies with various ISO standards and replaces the former CE mark for UK markets since the UK exited the EU."

“We know that scientists need to prepare samples quickly and efficiently, with consistent quality and accuracy. Therefore, they need the diagnostic stains to be consistently reliable and of high quality, before presenting their samples to a pathologist for diagnosis.

“Employing ready-to-use and validated stain kits in the laboratory saves the modern biomedical scientist time and provides consistent and reliable results within proven protocols. As our stain kits are independently assessed and scored by UK NEQAS CPT, and tested in our QC laboratory before supply, this provides the external, pre-validated quality assurance that any biomedical scientist can rely on.”