Examples of Reported problems
The manufacturer's claims don't quite fit our laboratory
A laboratory buys a CE-marked IVD, but its reference interval and clinical application
differs from the manufacturer's intended conditions.
The laboratory therefore can't simply rely on the manufacturer's performance data; it needs to establish that the method is fit for purpose locally
Examples of Reported problems
Laboratories using the assay outside the manufacturer's IFU.”
Examples include:
- different specimen type
- modified sample preparation
- different extraction method
- different instrument
- altered analytical parameters
- different clinical application
This is particularly relevant because the new UK guidance specifically addresses off-label IVD use (LabMed)
common laboratory problems reported
Our scientists know the assay — but nobody has time to run the validation properly.”
The laboratory may have excellent technical staff, but they are already responsible for:
- routine service
- staff management
- quality management
- EQA
- audits
- troubleshooting
- new equipment
- clinical reporting
A validation project gets pushed down the priority list leading to new instruments not put into clinical use results is waste of procurement resources and capital depreciations.
Recorded Adverse events due to laboratory non-compliance
Repeated near miss-incorrect reporting of APTT results
Does the management system of the laboratory include actions to address risks and opportunities for improvement as outlined in section 8.5 in ISO 15189, 2022.
Non Conformity: 'Standard not effectivity implemented in organizations Quality Management System: Root cause: Lack of understanding of requirements in clinical context'.
TTP, a rare disorder, misdiagnosed
Root cause: 'Specificity not performed in assay verification stages, Assay limitation not identified'.
Assay incorrectly used for monitoring therapeutic drugs
Assay not used for intended use, assay only verified for diagnosis and not for monitoring.
See ISO 15189 6.4.2.b - 'Where the equipment is used outside the laboratory's permanent control, or equipment manufacturer's functional specification, does laboratory management ensure that the requirements of this document are met'.