Clinical exams carried out by medical laboratories which are external or internal to hospitals, of material taken from human bodies, provide information regarding physiological or pathological processes as well as accurate diagnoses.
It is recognized that 70/80% of diagnoses are based on the results obtained by medical laboratories.
The accreditation of medical laboratories against the standard ISO 15189 foresees the verification of the adequacy of the management system and the technical competences, especially with regard to staff competences, the appropriateness of exams, the correct performance and transport of samples, the suitability of rooms, the comparison of results, the adequacy of response times and the clarity of the results.
Accreditation is therefore an essential tool for ensuring the quality of services provided by medical laboratories, in line with national and European goals for the protection of public health and the guarantee of safe healthcare.
Medical analyses refer to a number of laboratory disciplines:
In addition to the exams carried out at the medical laboratory, blood testing and point of care testing (POCT) can also be accredited.
POCT is a medical analysis undertaken away from the laboratory (at health clinics, surgeries etc.) and it may require the placing of instruments near the patient for the performance of exams.
Analyses are performed by medical laboratories accredited according to the ISO 15189.