These guide-lines provide a framework for the local arrangement of nea
r patient testing (NPT) services for haematology tests. The guidance m
ay be applied to medical and surgical units within hospitals (e.g. ITU
, renal dialysis units, casualty) as well as general practitioners' su
rgeries, for blood counts and coagulation testing, The professional he
ad 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. Eq
uipment selected should normally have received a satisfactory evaluati
on report from the Medical Devices Agency (MDA), and should generate r
esults that are comparable with those of the central laboratory. If a
full MDA operation evaluation has not been performed, the purchaser sh
ould perform a local assessment according to the protocol in this docu
ment, The suitability of the equipment, imprecision, and comparability
must be studied, The NPT equipment must be properly maintained and ca
librated, 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.