These guide-lines provide a framework for the local arrangement of near patient testing (NPT) services for haematology tests.
The guidance may be applied to medical and surgical units within hospitals (e.g. ITU, renal dialysis units, casualty) as well as general practitioners'surgeries, for blood counts and coagulation testing.
The professional head of the central laboratory must take responsibility for all aspects of the NPT service, although there should be full discussion with the clinical departments involved and joint ownership of the results.
NPT operators must be trained and accredited by the central laboratory.
Equipment selected should normally have received a satisfactory evaluation report from the Medical Devices Agency (MDA), and should generate results that are comparable with those of the central laboratory.
If a full MDA operation evaluation has not been performed, the purchaser should perform a local assessment according to the protocol in this document.
The suitability of the equipment, imprecision, and comparability must be studied.
The NPT equipment must be properly maintained and calibrated, and a record of patient identity, date and time of testing, reagent lot numbers, and operator must be kept.
The central laboratory must participate in a suitable external quality assessment programme (EQA), and provide systems for EQA and internal quality control (IQC) of the NPT site.
Mots-clés Pascal : Hématologie, Diagnostic, Essai, Contrôle qualité, Evaluation, Laboratoire, Analyse, Malade, Homme
Mots-clés Pascal anglais : Hematology, Diagnosis, Test, Quality control, Evaluation, Laboratory, Analysis, Patient, Human
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 96-0173165
Code Inist : 002B30A01C. Création : 199608.