Qualitätssicherung is everything that makes a number believable. For a pharmacy offering diagnostics it divides cleanly into two halves, and confusing them is how gaps appear.
The analytical half belongs to the laboratory. An akkreditiertes Labor has had its competence assessed for the methods in its accreditation scope, runs internal controls, and takes part in Ringversuche, the external comparisons in which laboratories analyse identical material and their results are compared. In Germany the framework for laboratory quality assurance in medical testing is the Richtlinie der Bundesärztekammer, usually shortened to RiliBÄK. A pharmacy sending samples out inherits that assurance and does not have to reproduce it.
The other half belongs to the pharmacy and no one else covers it. Whether the right person carried out the draw. Whether the sample was identified, handled and dispatched correctly, which is Präanalytik. Whether the training records and the Standardarbeitsanweisungen are current. Whether someone checks any of this on a schedule rather than when a problem appears.
Where a pharmacy measures a value itself, on a Point-of-Care-Test device, the analytical half comes home too. Then the device manufacturer's control procedure, the control material, the maintenance intervals and the record of who ran which check become the pharmacy's responsibility.
The Apothekenbetriebsordnung already requires a quality management system, so none of this is a parallel structure. Blood collection is a new chapter in a file that exists.
The useful test is a single question. If a customer challenged a result in six months, what document would answer them, and does it exist today.
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.
