Aufklärung is the explanation a person receives before a blood sample is taken, and 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 draw begins.
A workable Aufklärung covers the following points:
- The explanation covers what is being measured and for what reason.
- It covers how the draw itself is carried out in the pharmacy.
- It covers the risks that come with it, such as bruising or feeling faint.
- It covers what happens to the sample and to the data afterwards.
- It names who analyses the sample and how long the result takes.
- It states clearly 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 included in the general one. The two consents can be on the same form, provided they are separately given.
Delegation is the rule teams most often get wrong. Under § 11c Apothekengesetz the puncture may be handed to a Pharmazeut im Praktikum under supervision, but 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 the documentation, but 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.
