The room is the first physical blocker before a pharmacy can take a blood draw appointment, and welche Räumlichkeiten dürfen genutzt werden is a verbatim question in the ABDA pDL FAQ.
Most pharmacies already have the room, because the ApBetrO describes no treatment room and no minimum floor area. It describes how a room is used during the blood draw, so an existing Beratungsraum or the Nachtdienstzimmer can qualify without building work.
The step almost nobody mentions is the notification. The pharmacy notifies the state authority at least one week before the first blood draw, and again before any change to the procedure or the rooms.
Most pharmacies already have the room they need
The venöse Blutentnahme (venous blood draw) became lawful under § 11c ApoG on 2 July 2026, through the Apothekenversorgung-Weiterentwicklungsgesetz, covered in the ApoVWG guide. Article 3 of that law inserted § 35b into the ApBetrO and added § 2 Absatz 3b, both in force, while a separate ApBetrO-Änderungsverordnung is still pending.
The ABDA pDL FAQ answers at permit level first: a pharmazeutische Dienstleistung is delivered in rooms covered by the Apothekenbetriebserlaubnis, and § 4 ApBetrO requires Raumeinheit.
The rule governs the room only during the blood draw
§ 35b Absatz 3 ApBetrO sets four things. A geeignete Räumlichkeit with the equipment a blood draw needs is available for the Aufklärung (patient information and consent), the Anamnese and the draw. Using it must not disturb the ordnungsgemäßer Betrieb, the necessary Hygienemaßnahmen have to be implemented inside it, and the room may not be used for anything else during the blood draw. Unbefugter Zugriff to apothekenpflichtige Arzneimittel, Ausgangsstoffe und Chemikalien is excluded, and Privatsphäre is protected during the Aufklärungsgespräch as well as the draw.
§ 2 Absatz 3b adds equipment for den Umgang mit Komplikationen and a Betriebshaftpflichtversicherung covering harm from blood draws. § 35b Absatz 1 puts the process into the Qualitätsmanagementsystem under § 2a, where the Standardarbeitsanweisungen cover preparation, consent, Anamnese, the draw, documentation and hygiene.
| Requirement | In a real Offizin | Where it goes wrong |
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| Geeignete Räumlichkeit | A Beratungsraum with wipeable surfaces | The room doubles as a stockroom |
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| No other use during the blood draw | The room is blocked for the whole slot | Staff cross it to reach stock |
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| Privatsphäre throughout | A door that closes on the talk | Consent is taken at the counter |
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| No unbefugter Zugriff | Arzneimittel are locked away | The room chosen is the Laboratorium |
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| Umgang mit Komplikationen | Seating a person can be lowered in | A high stool with no back |
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| Anzeige one week ahead | Notice naming the rooms | A later change is not notified |
|---|
The pharmacy notifies the state authority one week before it starts
This duty sits in § 2 Absatz 3b rather than in § 35b with the room rules, which is why it gets missed. The Apothekenleiter notifies the zuständige Behörde of the blood draws and of the rooms intended for them at the latest one week before blood draws begin, and notifies changes to the procedure or the rooms a week before they take effect. The same pattern applies to Schutzimpfungen under § 2 Absatz 3a, covered in the post on vaccination in the pharmacy.
A pharmacy that later moves the blood draw into a converted Nachtdienstzimmer is therefore making a notifiable change. Which authority receives the notice depends on the Bundesland, because supervision sits with a Regierungspräsidium in one state and a Landratsamt in another, and no national form exists. [team to confirm] the notification form per Bundesland.
A consultation room becomes a blood draw station in six moves
Six changes are involved, and most are consumables rather than construction.
- Surfaces come first, because floors, work surfaces and equipment have to be easy to clean, resistant to the products used, and disinfected every working day.
- Seating is where the Komplikationen clause bites, because a person who feels faint needs to be lowered rather than steadied, so a reclining chair does more than a stool, with wound care material to hand.
- Hand hygiene needs a wash point with running warm and cold water, single use towels, a skin friendly cleanser, disinfectant in dispensers and a Hautschutzplan posted there.
- Waste handling is the part most consultation rooms have never needed, because infektionsverdächtige Abfälle go into suitable containers and sharp items into closable single use containers that are liquid tight, puncture proof and clearly labelled.
- Sample handling decides where the Präanalytik (pre-analytical phase) sits, because the analysis happens at an akkreditiertes Labor, so the room needs a defined place for tubes and a Standardarbeitsanweisung setting how long they may sit there. Point of care devices sharing the room, as in the post on capillary versus venous blood, add direct sunlight as a factor to avoid.
- Documentation finishes in the room under § 35b Absatz 5, which requires it in immediate time connection with the Aufklärung, the Anamnese and the draw, so a working surface belongs in the same protected space.
The Hygieneplan carries what the ApBetrO leaves unsaid
§ 35b says geeignete Hygienemaßnahmen and stops there, so the detail lives in the Biostoffverordnung (BioStoffV). The Bundesapothekerkammer guideline states that blood testing counts as a Tätigkeit mit Biostoffen, that blood is classified in Risikogruppe 3**, and that the work runs under Schutzstufe 2, with TRBA 250, 400 and 500 applying.
That produces a short list. The Apothekenleiter carries out a Gefährdungsbeurteilung, a Betriebsanweisung exists with instruction before starting and at least yearly, and a Hygieneplan covers the work area with annual training. Staff are offered hepatitis B immunisation and arbeitsmedizinische Vorsorge.
One caveat matters. The published standard and guideline were written for capillary screening tests, not for the venöse Blutentnahme, so a pharmacy reworks them, and whether a reworked plan satisfies the chamber varies by Bundesland.
The Medizinprodukte-Betreiberverordnung (MPBetreibV) reaches the room through the devices in it. Where blood testing is not already regulated in the Qualitätsmanagementsystem under § 2a, the same guideline treats a Qualitätssicherungssystem under § 9 MPBetreibV as obligatory, with the RiliBÄK giving the detail.
The room sets how many appointments fit into one day
Because the room may not be used for anything else during a blood draw, it becomes a single channel resource, and that is the real constraint on volume, not staff training. One appointment occupies it for the Aufklärung, the Anamnese, the consent, the draw, the documentation and the cleaning.
The same standard puts a capillary test at 5 to 10 minutes per patient, and a venöse Blutentnahme with a full Aufklärung runs longer, with no published German figure yet. [team to confirm] a realistic slot length. Where the room also carries Grippeimpfung slots, the services compete for the same hours.
A pharmacy without a spare room still has options
The Nachtdienstzimmer is already a Betriebsraum under § 4 Absatz 2 ApBetrO and stands empty during opening hours, which makes it the obvious candidate. The Laboratorium has cleanable surfaces but holds the Ausgangsstoffe und Chemikalien that § 35b Absatz 3 wants out of reach, so it works only if those are locked.
A partitioned corner of the Offizin is the weakest option, because § 4 Absatz 2a already asks for confidential counselling there and § 35b Absatz 3 asks for more. Batching appointments into blocks keeps a shared room usable and is often more realistic than converting space, as the post on self pay services in the pharmacy sets out.
Pharmacy owners ask these questions about the blood draw room
Does a pharmacy need a separate treatment room for the venöse Blutentnahme?
No. § 35b Absatz 3 ApBetrO asks for a geeignete Räumlichkeit with the equipment a blood draw needs, not a purpose built room. The conditions are that it is not used for anything else during the blood draw and that Privatsphäre is protected.
Can one room be used for vaccinations and for blood draws?
Yes, because neither § 35a nor § 35b ApBetrO reserves a room for a single service. Both block the room for the whole appointment, so the services compete for hours rather than square metres.
Who receives the one week notification?
The zuständige Behörde for pharmacy supervision, which differs by Bundesland and can be a Regierungspräsidium or a Landratsamt. The ApBetrO prescribes no national form, so the responsible Apothekerkammer answers locally.
Does a Hygieneplan for capillary testing cover the venöse Blutentnahme?
Not without revision. The published Bundesapothekerkammer standard was written for capillary screening tests, so the Gefährdungsbeurteilung, the Betriebsanweisung and the Hygieneplan are reworked for the venous procedure, and the responsible chamber decides whether that is accepted.
A pharmacy starts with three practical moves
The first move is walking the existing rooms against the six requirements in the table, which usually settles the question without a builder. The second is drafting the Standardarbeitsanweisungen and the reworked Hygieneplan. The third is putting the notification in the calendar a week before the first booking.
This is general information about German pharmacy law and business practice, not legal advice. The responsible Apothekerkammer or a lawyer decides individual cases.
