Chapter 3 · LIS downtime procedures

Every laboratory must have a documented downtime procedure for both planned and unplanned LIS outages. It must cover: manual request and result recording, specimen labelling during downtime, how results are communicated to clinicians, and the process for entering downtime results into the LIS when restored. Downtime procedures must be tested at planned intervals and staff must be trained on them before they need them.

Chapter 3 · Practical example

LIS downtime — maintaining patient safety without system support

The laboratory must have a documented downtime procedure that maintains result safety and patient care continuity when the LIS is unavailable.

▲ The situation

The LIS fails at 08:30 on a Monday morning. Forty patient samples from the morning clinic are in the laboratory. The IT department estimates four to six hours before restoration. The section head must decide how to proceed.

Reference: ISO 15189:2022 Clause 7.8.6

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Good practice

The section head activates the documented downtime procedure: pre-printed downtime worksheets are used for result recording. Urgent samples are processed and results telephoned to clinicians immediately. Critical value notifications continue as normal using telephone. All downtime results are recorded against accession numbers on paper. When the LIS is restored at 14:00, two scientists enter all downtime results simultaneously, with a third scientist verifying each entry against the paper record.

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Poor practice

The section head waits for the LIS to be restored before processing any samples. Six hours of clinical laboratory work is paused. Clinicians waiting for urgent results — a troponin for a patient in the ED, an INR for a patient with a supratherapeutic warfarin level — are told the lab is down. The delay has direct patient consequences.

● What this means for your practice

A laboratory downtime procedure is not optional infrastructure — it is a patient safety requirement. The goal during downtime is to maintain clinical laboratory service at the same level as normal operations. Test the downtime procedure at least annually so that all staff know what to do without being told.