Publications by authors named "M Panteghini"

The main stakeholders in external quality assessment (EQA) programs are the participants, in whose interests these challenges are ultimately organised. EQA schemes in the medical field contribute to improving the quality of patient care by evaluating the analytical and diagnostic quality of laboratory and point-of-care tests (POCT) by independent third parties and, if necessary, pointing out erroneous measurement results and analytical or diagnostic improvement potential. Other benefits include the option of using EQA samples for other important laboratory procedures, such as the verification or validation of diagnostic medical devices (IVD-MDs), a contribution to the estimation of measurement uncertainty, a means of training and educating laboratory staff through educational EQA programmes or samples, or even for independent and documented monitoring of staff competence, such as on samples with unusual or even exceptional characteristics.

View Article and Find Full Text PDF
Article Synopsis
  • The EN ISO 15189:2022 standard updates regulations for medical laboratories, replacing previous versions and aiming for better quality and competence.
  • The revision focuses on aligning with ISO/IEC 17025:2017, enhancing patient safety, and providing clearer guidelines while minimizing new requirements.
  • A guidance document from the EFLM Committee has been produced to help laboratories and accreditation bodies understand and implement these changes effectively.
View Article and Find Full Text PDF

Correct measurement results from in vitro diagnostic (IVD) medical devices (MD) are crucial for optimal patient care. The performance of IVD-MDs is often assessed through method comparison studies. Such studies can be compromised by the influence of various factors.

View Article and Find Full Text PDF

Poor analytical quality may be the bane of medical use of laboratory tests, and the fight against excessive analytical variability presents a daily struggle. Laboratories should prioritize the perspectives and needs of their customers (the patients and healthcare personnel). Among them, comparability of results from the same patient sample when measured by different laboratories using different diagnostic (IVD) medical devices is a logical priority to avoid result misinterpretation and potential patient harm.

View Article and Find Full Text PDF
Article Synopsis
  • - Commutable secondary certified reference materials (CRMs) are crucial for ensuring consistent results in medical lab tests, highlighting the need for their sustainable availability.
  • - The IFCC Working Group has released recommendations for assessing the commutability of these CRMs, although detailed studies can strain resources for producers.
  • - A new equivalence assessment method allows for comparing replacement CRMs with established ones, potentially reducing resource needs while ensuring reliability through the inclusion of representative clinical samples.
View Article and Find Full Text PDF