IG-07 Something Went Wrong — LAB-QM-010 / LAB-QM-011

1 · Classify it — QM-010 §5.2

Minor
No impact on patient safety, result accuracy, or compliance — e.g. a minor delay caught before any clinical impact; a transient, non-systemic error.

Major
Actual — or high-risk potential — impact on patient care, diagnosis, result integrity, or staff safety: an erroneous report issued, a mislabeled specimen tested, a critical value not notified.

Sentinel event
Death, permanent harm, or severe temporary harm. Escalate immediately to the Hospital Director and Pathologist for hospital-wide review (§5.5).

2 · Report & contain — §5.3–§5.4

Report on F-QM-010-A-V0 as soon as possible during the same shift — no later than 24 hours after discovery.
Active risk to a patient, or a wrong result already released? Phone the CMT/LQM or attending physician immediately.
Halt affected testing; quarantine suspect analyzers, reagents, or supplies.
Withhold or recall questionable results; if a wrong result was released, issue an amended report.
Sharps injury or exposure? Immediate medical evaluation and prophylaxis.
Log the occurrence in the master log of F-QM-010-A-V0.

Deviations (§5.6): a planned deviation needs a written justification in advance and the Pathologist's written authorization — valid for one batch/event only. An emergency deviation is documented and submitted to the Pathologist within 24 hours.

3 · What happens next — §5.5 + QM-011

Minor, isolated, corrected on the spot → closed locally in F-QM-010-A-V0.
Major, recurring, or systemic → formal CAPA on F-QM-011-A-V0, with root-cause analysis:
5 Whys — straightforward, single-factor problems.
Fishbone — complex/systemic: Personnel · Equipment · Materials · Methods · Measurement · Environment.
Plans touching analytical procedure, interpretation, or patient safety need the Pathologist's written approval; budget/admin plans need the Hospital Director's.
Effectiveness is checked after 30–90 days of monitoring. Not effective? The CAPA re-opens for deeper analysis.
Occurrences are trended monthly; CAPAs are trend-reviewed quarterly (QM-011 §5.7).