The quality assurance obligation on a blood test depends almost entirely on whether the pharmacy measures the sample itself in the Offizin or sends it to an akkreditiertes Labor. Most owners do not realise how far the paths differ, because the guidance covers the measuring path and barely mentions the other.
Measuring in the Offizin makes the pharmacy the operator of a measuring device, which brings Gerätekontrolle, Systemkontrolle, a Qualitätskontrollkarte, Fehlergrenzen from the Richtlinie der Bundesärztekammer, an annual Ringversuch that the Bundesapothekerkammer recommends and the duties of the Medizinprodukte-Betreiberverordnung (MPBetreibV). Sending the sample moves the analytical part to a laboratory that already holds accreditation and runs its own Qualitätssicherung.
The sending path became practical after § 11c of the Apothekengesetz (ApoG) came into force on 2 July 2026 through the Apothekenversorgung-Weiterentwicklungsgesetz (ApoVWG), which allows an approbierter Apotheker to carry out a venöse Blutentnahme after an ärztliche Schulung. What no path removes is Präanalytik.
RiliBÄK is a doctors chamber rule that reaches pharmacies indirectly
RiliBÄK is short for the Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen, announced in the Deutsches Ärzteblatt on 30 May 2023 and amended in August 2025. Teil B1 covers quantitative tests and carries the Fehlergrenzen tables a pharmacy uses. It binds through the MPBetreibV, because § 10 Abs. 1 obliges anyone carrying out laboratoriumsmedizinische Untersuchungen to set up a Qualitätssicherungssystem before starting, and following the RiliBÄK is presumed to meet that standard. Records are kept five years.
The RiliBÄK presents itself as a rule for laboratory medicine carried out in the practice of medicine, and the sources reviewed do not say plainly whether a blood test sold as a Selbstzahlerleistung sits inside that wording. The question decides less than it looks, because the Bundesapothekerkammer imported the Fehlergrenzen into its own Leitlinie anyway.
Interne Qualitätskontrolle is a routine at the Messplatz
Interne Qualitätskontrolle has two halves. Gerätekontrolle is the check on the device at minimum once on each day of use, covering operating temperature, cleanliness, correct coding and the release for measurement. Systemkontrolle is the measurement of a control sample of known concentration, run per device and per analyte, with the number of measurements scaled to weekly volume.
RiliBÄK Teil B1 treats Unit-use-Reagenzien separately in Point-of-Care-Test settings, where the manufacturer's control instructions are followed and documented and one control measurement falls in any week with patient samples. Fehlergrenzen come from Tabelle B1-2, with Glucose at 5,0 percent and Gesamtcholesterin at 7,0 percent. The glucose limit was tightened from 11 percent in 2023, with a transition that ran to 30 May 2026.
When a control measurement falls outside those limits, the device is blocked for further tests and marked in red until the deviation is explained. The pharmacy finds the cause, removes it, repeats the control measurement and writes each step on the Qualitätskontrollkarte, kept at the Messplatz with the Hygieneplan.
Ringversuche compare one pharmacy against every other participant
A Ringversuch is external quality assurance. A provider sends samples whose true concentration the participant does not know, the participant measures them on its own device, and the provider compares the results against the assigned value using the RiliBÄK Fehlergrenzen. For pharmacies the Blut-Ringversuch is run by the Zentrallaboratorium Deutscher Apotheker e.V. in Eschborn, which sends two or more samples per registered device and parameter, evaluates within eight weeks and issues a certificate valid twelve months.
Its legal status matters more than most owners expect. The Bundesapothekerkammer recommends yearly participation alongside internal quality control and wrote that into its Leitlinie, while ApBetrO § 2a asks the Apothekenleiter for regular external quality review without naming a frequency. RiliBÄK Teil B1 sets one Ringversuch per quarter for laboratory sites, and it exempts investigations with Unit-use-Reagenzien in patientennaher Sofortdiagnostik in wording drafted around Arztpraxen and hospitals. Whether an Offizin falls inside that exemption is not stated in the sources reviewed.
A failed Ringversuch does not close the service, because the Kommentar asks for the cause to be found and removed rather than a ban. What lapses is the certificate, the simplest evidence a pharmacy can show a doubting doctor.
Measuring in the Offizin and sending to a laboratory differ sharply
| What is at stake | Measuring in the Offizin | Sending to an akkreditiertes Labor |
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| Answers for the analytical result | The pharmacy, as device operator under MPBetreibV | The laboratory, under DIN EN ISO 15189 |
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| Quality control work | Gerätekontrolle and Systemkontrolle daily, plus an annual Ringversuch | Carried by the laboratory under its accreditation |
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| Documentation kept | Qualitätskontrollkarte, Hygieneplan, device records, five years | Aufklärung, Anamnese, identification, storage and transport |
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| Where the time goes | Control runs before patient samples, blocked device handling, card entries | Labelling and Probenlogistik on the day, the Befund conversation later |
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MPBetreibV duties start when a pharmacy operates a measuring device
A pharmacy that measures becomes the Betreiber of an In-vitro-Diagnostikum. Only staff with the required qualification, knowledge and experience operate the device, an Einweisung is given and repeated after a software update that changes handling, maintenance follows the manufacturer's specification, active devices go into a Bestandsverzeichnis, and the quality assurance system under § 10 sits behind it. The Leitlinie adds surfaces that are easy to clean, control material stored dry between 2 °C and 30 °C, and devices conforming to Verordnung (EU) 2017/745 or 2017/746.
This is where two similar products part company. Under Verordnung (EU) 2017/746 a self test is a Produkt zur Eigenanwendung intended for a layperson, while a product for patientennahe Tests is intended for use outside a laboratory by a health professional. Selling the first over the counter leaves the measurement with the customer, while running the second puts the operator duties, the control measurements and the records on the pharmacy, a difference explored in self tests against laboratory tests.
Präanalytik stays with the pharmacy on both paths
Präanalytik is everything that happens to the sample before analysis, and it is where most laboratory error is created. LaborPraxis, citing Lippi and colleagues in Clinical Chemistry and Laboratory Medicine, reports that more than 60 percent of errors in plasma and serum analytics arise there, against roughly 15 percent in the analysis itself.
That share does not travel to the laboratory with the sample. Identification, the Aufklärung and the Anamnese on fasting and medication, the choice of tube, the avoidance of Hämolyse, storage temperature and the transport window stay with the pharmacy that took the sample, which is why Probenlogistik is the part of the lab path a pharmacy builds itself. How a kapillare Blutentnahme differs is set out in capillary and venous blood compared.
The ABDA Leitlinie names the documents a pharmacy holds
Most of this comes from the Leitlinie der Bundesapothekerkammer on "Physiologisch-chemische Untersuchungen: Durchführung der Blutuntersuchungen", version 14 May 2024, updated 26 March 2025. It carries a Kommentar and four Arbeitshilfen: a Standardarbeitsanweisung, a Formblatt for the Qualitätskontrollkarte, a checklist and a Formblatt for the Hygieneplan. Together they ask for a quality assurance system under MPBetreibV, documented Gerätekontrolle and Systemkontrolle, Fehlergrenzen from RiliBÄK Teil B1, a blocking rule, an annual Ringversuch and hygiene following the Biostoffverordnung. That is a standing routine rather than a laboratory in disguise, and Hygiene bei der Blutentnahme applies either way.
Questions pharmacy owners ask about blood test quality assurance
Does the RiliBÄK apply to a pharmacy that measures blood in the Offizin
The RiliBÄK is written for laboratory medicine and reaches operators through § 10 MPBetreibV, which binds anyone performing laboratoriumsmedizinische Untersuchungen. The sources reviewed do not say whether a blood test sold as a Selbstzahlerleistung sits inside that wording, and the answer rarely matters, because the ABDA Leitlinie imports the Fehlergrenzen anyway.
Is a Ringversuch legally required for a pharmacy
The Bundesapothekerkammer recommends yearly participation alongside internal quality control, and ApBetrO § 2a asks for regular external quality review without naming a frequency. RiliBÄK Teil B1 sets one Ringversuch per quarter for laboratory sites and exempts Unit-use-Reagenzien in patientennaher Sofortdiagnostik.
What happens when a control measurement falls outside the Fehlergrenzen
The device is blocked for further tests and marked until the deviation is explained. The pharmacy finds the cause, corrects it, repeats the control measurement and records each step on the Qualitätskontrollkarte, so a waiting customer leaves without a result.
Does sending the sample to an akkreditiertes Labor remove the obligations
It moves the analytical part, because the laboratory carries its own accreditation to DIN EN ISO 15189 and its own external quality assurance. Präanalytik, identification, labelling, storage and transport stay with the pharmacy, together with the Aufklärung and Anamnese records.
Is a self test sold over the counter treated like a measurement in the Offizin
No. Under Verordnung (EU) 2017/746 a self test is a Produkt zur Eigenanwendung intended for laypersons and the customer runs it, while staff measuring with a professional device make the pharmacy the Betreiber under MPBetreibV.
What a pharmacy does next
The practical order is to settle the path first and read the obligations second, because reading the Leitlinie first gives the impression that every pharmacy needs a laboratory. A pharmacy that wants a measured value within minutes accepts Gerätekontrolle, Systemkontrolle, the Qualitätskontrollkarte and an annual Ringversuch as a permanent routine, while a pharmacy that wants a broad panel with a Referenzbereich on a printed Befund accepts Probenlogistik and a delay instead. Either way a Standardarbeitsanweisung sits in the Qualitätsmanagementsystem, and whether a PTA can be involved is answered in what a PTA may and may not do at the draw.
This article is general information about German pharmacy law and business practice. It is not legal advice, and the responsible Apothekerkammer or a lawyer decides individual cases.
