nonconforming work

Nonconforming work is laboratory activity or output that does not meet applicable requirements or the laboratory's own established conditions. It can arise before, during, or after examination. Examples include processing an unsuitable specimen, using an examination system after an unresolved control failure, or issuing a report with incorrect patient details. The central question is whether the work or its result remains fit for use.

The response may include stopping work, withholding reports, assessing clinical significance, reviewing previously released results, notifying users, and authorizing a safe restart. Responsibilities and decision authority should be defined in advance. Not every event has the same consequences, so evaluate the extent and patient impact rather than applying a single response to all failures. Record the rationale for decisions.

Accreditation assessment looks for timely control of unsafe or unreliable work, not just completion of an incident form. Records should show what was affected, how patients and users were protected, and who approved resumption. Link significant or recurring events to corrective action, and check whether related results, instruments, shifts, or locations also require review.