Aufklärung is the explanation a person receives before a blood sample is taken. Einwilligung is the consent they give afterwards, on the basis of that explanation. The two are separate steps and both have to happen before the needle.
A workable Aufklärung covers what is being measured and why, how the draw is carried out, the risks that come with it such as bruising or feeling faint, what happens to the sample and to the data afterwards, who analyses it, how long the result takes, and the point that a measured value is not a diagnosis.
The Einwilligung has to be informed and should be documented. Health data is a special category under Article 9 of the Datenschutz-Grundverordnung, so the data side normally needs its own explicit consent rather than being folded into the general one. The two consents can sit on the same form provided they are separately given.
The rule that catches teams out is delegation. Under § 11c Apothekengesetz the puncture may be handed to a Pharmazeut im Praktikum under supervision. Aufklärung, Anamnese and consent may not be handed to anyone. They stay with the pharmacist carrying out the venöse Blutentnahme. A PTA may prepare the room and handle documentation, and may not conduct the Aufklärung.
One eligibility point belongs in the same conversation, because it is checked at this moment rather than later. The service is limited to people aged 18 or over.
How all of this is carried out and recorded belongs in the pharmacy's Standardarbeitsanweisungen, including which form is used and where the signed consent is stored.
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.
