Aufbewahrungsfristen

Aufbewahrungsfristen are the periods for which a pharmacy has to keep a document before it may be destroyed. A blood draw produces more paper than it appears to from the counter:

• A signed Aufklärung und Einwilligung has to be kept.
• The request form sent to the laboratory has to be kept.
• The result that came back from the laboratory has to be kept.
• The record of who drew the blood and when has to be kept.
• The logs of the centrifuge, the fridge and any device used have to be kept as well.

The useful principle is that the retention period follows the type of document rather than the place where it was created. A pharmacy tends to assume that everything generated in the pharmacy falls under one pharmacy rule and expires together, which is not the case.

Consent and anything else tied to an identified person is patient documentation, governed by the rules for health records, which are long by the standards of retail paperwork. A defence against a claim is only as good as the file that supports it, which is a second reason to keep those records. Laboratory requests and results belong to the same family, since they identify a person and a finding.

Device and process records belong in a different category, because temperature logs, maintenance records, calibration and cleaning plans are Qualitätssicherung documents. They prove that the process was under control on a given day rather than what happened to a given customer, so their retention is driven by the quality management system and the equipment rules.

Training records and the current and previous versions of the Standardarbeitsanweisung belong here too, and superseded versions are worth keeping precisely because they state what the instruction said at the time of an incident. Invoices and anything with a tax character follow commercial law and have nothing to do with the clinical side at all.

Two practical consequences follow from that:

1. A retention plan is written per document type and noted in the SOP, so nobody has to reason it out while clearing a cupboard.
2. The longest relevant period applies when a document could belong to two categories, because early destruction is the one mistake that cannot be repaired and it becomes a question of Haftung.

Exact periods differ by document type and by federal state, so the specific figures are worth confirming with the Landesapothekerkammer before the plan is signed off.