pre-examination process

The pre-examination process includes the activities that occur before the examination itself, from the request and patient preparation through specimen collection, identification, transport, receipt, and preparation. It often crosses organizational boundaries, involving clinical teams, collection centres, couriers, and laboratory reception. Failures in this pathway can invalidate results even when the analytical procedure performs correctly.

Controls should address the information supplied to users, patient and specimen identification, suitable containers, collection conditions, transport requirements, and acceptance or rejection criteria. Staff need a clear approach to urgent or irreplaceable specimens that do not meet normal requirements, including authorization and communication of limitations. Map handovers explicitly, because unclear responsibilities between organizations can leave gaps that are not visible from the laboratory bench alone.

Accreditation review examines whether the laboratory manages risks before samples reach the analyzer, including activities performed by others on its behalf. Evidence may include user instructions, transport checks, rejection records, and communication with collection services. Monitor meaningful indicators and investigate recurring failures so responsibility for specimen quality does not disappear at organizational boundaries.