Diagnostics in the pharmacy

Qualitätssicherung

In one sentence

Qualitätssicherung is the set of checks that make a result trustworthy, which means trained people, maintained devices, written procedures and external comparison. In a pharmacy it divides between what the laboratory guarantees and what the pharmacy itself controls.

Qualitätssicherung is everything that makes a number believable. For a pharmacy offering diagnostics it divides 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 nobody else covers it.

Somebody has to confirm that the right person carried out the draw.
Identifying, handling and dispatching the sample correctly is Präanalytik and belongs to the pharmacy.
The training records and the Standardarbeitsanweisungen have to be current.
Somebody has to check all 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 becomes the pharmacy's responsibility as well. The device manufacturer's control procedure, the control material, the maintenance intervals and the record of who ran which check all belong to the pharmacy then.

The Apothekenbetriebsordnung already requires a quality management system, so none of this is a parallel structure, and blood collection is a new chapter in a file that exists.

The useful test is one question, namely what document would answer a customer who challenged a result in six months, and whether that document exists 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.

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PräanalytikPräanalytik covers everything that happens to a blood sample before it is analysed, from preparation and identification through collection, storage and transport. Most laboratory errors arise here rather than in the analysis itself.

Point-of-Care-TestA Point-of-Care-Test is a rapid test carried out where the person is, with the result available within minutes. It suits screening and orientation, but it does not reach the analytical range or the precision of an accredited laboratory analysis.

StandardarbeitsanweisungA Standardarbeitsanweisung, often called an SOP, is a written instruction in a pharmacy's quality management system. Written Standardarbeitsanweisungen have to be in place before a pharmacy carries out its first venöse Blutentnahme.

AufbewahrungsfristenAufbewahrungsfristen are the periods a pharmacy must keep the records a blood draw produces. Consent, the request form, the result and the device logs fall into different categories, and the period follows what the document is rather than where it was written.

Interne QualitätskontrolleInterne Qualitätskontrolle is the routine measurement of control samples with known target values on the pharmacy's own device and on its own schedule. It confirms that the device and the current reagent lot are still measuring correctly.

HygieneplanA Hygieneplan is the written plan stating which work surface, hands and instruments are cleaned or disinfected at a draw or measuring station, with which product, how often and by whom. The Betriebsanweisung for the activity belongs beside it.

KalibrierungKalibrierung sets a measuring device against material of known value so that its readings are traceable to a reference. It fixes the scale on which results are read, while a control measurement only checks that the scale still holds.

Diagnostics in your pharmacy

Aniva supplies the laboratory network, the test kits, the shipping and the data protection paperwork. Your pharmacy offers the venöse Blutentnahme and pharmazeutische Dienstleistungen under its own name. Core panel results are usually in the app within 10 days, while a few add-on panels take longer.

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Qualitätssicherung

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