In one sentence
Systemkontrolle is the routine check that the whole measuring system still works, meaning the device, the strip or cassette, the reagent and the person operating them, rather than any single part of that chain on its own.
Systemkontrolle is the check that the entire measuring system is still doing what it should, which means much more than the instrument on its own. The system is the device together with the strip or cassette currently in use, the reagent lot, the control material and the person performing the measurement. A check limited to the instrument leaves out most of the places a wrong number actually comes from.
In practice it is a measurement of control material with a known target value, run exactly as a customer sample would be run, by someone who runs them, on the consumables presently in the drawer. The result is compared with the acceptable range and recorded with the date, the device, the lot number and the initials of whoever carried it out. That record is the evidence that the system was sound at that hour, and it belongs in the pharmacy Standardarbeitsanweisung as a fixed step rather than a habit, so the schedule survives a change of shift.
Two other checks are confused with it often enough to be worth separating:
- Kalibrierung sets the scale on which values are read, and it happens before any control material is measured.
- A Ringversuch is external comparison, because an unknown sample arrives from outside and the pharmacy result is judged against other participants.
Within the pharmacy itself the routine check and the wider interne Qualitätskontrolle describe the same daily work seen from slightly different angles. The schedule is taken from the Gebrauchsanweisung of the device, and it usually requires a check at these moments:
- A check belongs at the start of every testing session.
- Every new lot of strips or reagent needs its own check.
- Maintenance and any repair are both followed by a check.
- Storage conditions that have been in doubt require one as well.
A failed check has consequences for measurements that were already taken. The Point-of-Care-Test is withdrawn for that parameter until the cause is found, and every result measured since the last good check is treated as unconfirmed, including the ones already handed to customers that day. The pharmacy notes which measurements belong in that window, contacts those people and offers a repeat measurement, without commenting on what the earlier value might have meant.
This glossary entry is general information about German pharmacy law and practice. It is not legal advice. For binding guidance on your own pharmacy, contact your Landesapothekerkammer.
