The course will provide an overview of different models to set performance specifications in laboratory medicine; 1) based on clinical outcome, on 2) biological variation, and 3) state of the art. In addition, it will address the total error concept, and performance specifications in external quality assessment schemes and in the extra-analytical phases.
The availability of highly sensitive troponin assays (hsTn) allows the safe clinical application of international recommendations and the introduction of fast-track protocols for the definition of AMI. However, hsTn assays have not always been welcomed by clinicians, claiming an increase in false-positive results. To guide interpretation of results, laboratory specialists need to get involved in communicating with clinicians through education, test interpretation and internal audits of test usage and patient outcomes. Since natriuretic peptides were successfully integrated into the clinical practice of heart failure (HF), the possibility of using new biomarkers to advance the management of affected patients has been explored. However, very few have made the difficult translation from initial promise to clinical application. These markers mirror the complex pathophysiology of HF: fibrosis (ST2 and galectin-3), infection (procalcitonin), and renal disease (renal markers). Traditional predictors suboptimally predict cardiovascular disease in individuals with chronic kidney disease (CKD). Recent studies propose new cardiac and kidney markers for the improvement of cardiovascular prediction among those subjects with CKD.
- Teacher: Mauro Panteghini
A recording of a plenary presentation by professor Mauro Panteghini, recorded at 4th Joint EFLM-UEMS Congress: Warsaw, Poland, 21–24 September, 2016
Harmonization in laboratory testing is more than merely analytical harmonization. Although the focus was mainly on the standardization and harmonization of measurement procedures and their results, the scope of harmonization goes beyond method and analytical results. It includes all aspects of the total examination process from the “pre-pre-analytical” phase through analysis to the “post-post-analytical” phase. Rapidly available and precise results can indeed be of very limited value if they cannot be compared with each other, are produced on a wrong material or within an inappropriate diagnostic workflow. In particular, as evidence collected in last decades demonstrates that pre-pre- and post-post-analytical steps are more vulnerable to errors, harmonization initiatives should be performed to improve procedures and processes at the laboratory–clinical interface. Managing upstream demand, down-stream interpretation of laboratory results, and subsequent appropriate action through close relationships between laboratorians and clinicians remains a crucial issue of the laboratory testing process. Therefore, initiatives to improve test demand management from one hand and to harmonize procedures to improve physicians’ acknowledgment of laboratory data and their interpretation from the other hand are needed in order to assure quality and safety in the total examination process. A harmonized context will increase the value of laboratory results facilitating their interpretation and thus improving the patient’s outcome.
- Teacher: Mauro Panteghini