Akkreditiertes Labor

An akkreditiertes Labor has been assessed by a national accreditation body and found technically competent to carry out defined analyses. For medical laboratories the relevant standard is DIN EN ISO 15189, and in Germany the assessment is carried out by the Deutsche Akkreditierungsstelle.

The distinction from a zertifiziertes Labor is not a nuance. Certification assesses whether a management system meets a standard. Accreditation assesses whether the laboratory can actually produce correct results for the analyses listed in its accreditation scope. Copy that uses the two words interchangeably says something factually different from what it means, and in German pharmacy communication that is worth avoiding.

For a pharmacy the practical requirements are short. A route to an akkreditiertes Labor has to exist before the first venöse Blutentnahme. The laboratory sets the Präanalytik requirements the pharmacy has to follow. The Referenzbereich printed on the report comes from that laboratory and is the only one that applies to that result.

It is worth checking that the specific analyses a pharmacy plans to offer sit inside the laboratory's accreditation scope, since accreditation is granted per method rather than to the building.

A Point-of-Care-Test produces its result on the device instead, outside this chain, which is exactly why its result and a laboratory report are not directly comparable.