Common Laboratory Compliance Issues
Many laboratories unknowingly introduce compliance risks when implementing assays. Examples include:
- Failure to identify a Laboratory Developed Test (LDT) and incorrectly treating the assay as a fully CE-marked or UKCA-marked diagnostic procedure.
- Modifying a manufacturer's instructions for use (IFU) without documenting and validating the impact of the change.
- Using different reference ranges from those established or recommended by the manufacturer without appropriate verification.
- Changing reagent lots, calibrators, controls, or analyser settings without assessing the effect on assay performance.
- Performing tests outside the manufacturer's intended use population, clinical application, or specimen type.
- Inadequate analytical validation following method modifications, including assessment of precision, accuracy, linearity, sensitivity, or reference intervals.
- Insufficient staff training and competency assessment before introducing a new or modified method.
- Failure to maintain documentation that demonstrates compliance with ISO 15189 and IVDR/UK MDR requirements.
- Lack of periodic review when clinical guidelines, treatment pathways, or therapeutic approaches change.
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
Repeated near-miss incidents involving incorrect reporting of APTT results. The laboratory management system did not effectively implement actions to address risks and opportunities for improvement in accordance with ISO 15189:2022 Clause 8.5.
TTP (Thrombotic Thrombocytopenic Purpura) misdiagnosis
The assay verification process did not include assessment of analytical specificity and potential cross-reactivity. Consequently, known assay limitations and interfering factors were not identified or documented before implementation. This resulted in inappropriate interpretation of test results and contributed to the misclassification of a patient with suspected TTP.
Assay incorrectly used for monitoring therapeutic drugs
An assay was used for therapeutic drug monitoring despite being verified and validated only for diagnostic purposes. The laboratory did not ensure that use of the assay outside its verified intended use met the requirements of ISO 15189:2022 Clause 6.4.2(b).