POCT accreditation based on ISO standards 15189

and 22870 in Germany

Ralf Bauerndistel, Dr., Lead Assessor German Accreditation Body (DAkkS), Germany
Beside for example the accreditation of ambassadors, the
accreditation of degree programs and the accreditation of
journalists and along the Regulation (EC) No 765/2008, Article
2(10), accreditation is the formal and independent confirmation of
competence of a conformity assessment body (CAB) by a national
accreditation body (NAB). In contrast to a certification based on e. g.
ISO 9001 - the confirmation of conformity - the accreditation brings
confidence in services, certificates or reports and supports economic
value and credibility.
The DAkkS (Deutsche Akkreditierungsstelle) is the NAB of Germany,
which was founded at the end of 2009 due to the European
Regulation (EC) No 765/2008. The DAkkS is supported by three
types of shareholders - the industry, the federal states and the
Federal Government of Germany. The DAkkS has three locations in
Berlin, Braunschweig and Frankfurt a. M., more than 160 employees
and about 1000 external assessors. The DAkkS is subject to
supervision by the Federal Government of Germany and is working
on a non-profit basis. Furthermore, it is DAkkS is member of
international accreditation networks like EA, IAF and ILAC.
The DAkkS uses the industry-specific standard DIN EN ISO
15189:2014 (Medical laboratories - Requirements for quality
and competence (ISO 15189:2012, Corrected version 2014-08-15);
German version EN ISO 15189:2012) as the basis for accreditation
of medical laboratories. In case that medical laboratories carry out
POCT examinations as well, the DIN EN ISO 22870:2006 (Point-ofcare testing (POCT) - Requirements for quality and competence) is
additionally used as a basis. In some points the 22870 supplements
the 15189 with additional requirements, in other respects the 22870
refers to the 15189 only.
The revision of the 22870 is postponed although it refers to the DIN
EN ISO 15189:2003. For this reason a working group of the national
NAMed committee is developing a table of crossreferences
whilst other national committees are currently elaborating special
requirements / interpretations on certain points of the 22870 like
the DIN 58964 (Quality assurance of POCT results - Assessment
criteria for comparison measurement and implementation). The
crossreferences have been implemented already in the checklist
to the 22870 provided on the DAkkS website. Edited by the
laboratory the checklist represents an important document for the
assessment.

Abstract

Ralf Bauerndistel

Meanwhile the EA Laboratory Committee working group on

Healthcare - Laboratory Medicine developed a Guidance for the
Assessment of Laboratories against EN ISO 15189 and EN ISO
22870 Point-of-Care Testing (POCT) (EA-4/20 G:2014), published
on 9th of December 2014. This guidance document is intended for
accreditation bodies that assess POCT in the field of laboratory
medicine and for medical laboratories, which are responsible for
POCT.
A relevant point of the guidance document is the postulation that
The accreditation body should have a clear policy for identifying
and assessing all key sites of POCT and all sites where POC
tests are performed during an accreditation cycle. A plan should
be documented by the accreditation body to plan appropriate
assessment activities for all sites over the accreditation cycle.. The
policy is still in preparation. But, to meet this requirement already
foresighted, common practice had long been that the laboratory
ahead of every assessment submits a list with identification of
the location (address, clinic, ward, etc.), with identification of the
relevance (critical, non critical area) and identification of the output
(high, medium, low output). In collaboration with the technical
assessors the file manager selects a sample of three sites at every
postal address to be assessed. In the sampling exercise critical
(where POCT results are critical to patient care, for example
accident and emergency rooms and operating theatres) and highthroughput sites will be considered and assessed first. At the next
assessment another sample from the list will be chosen, so that
during the whole accreditation cycle all or at least all key sites from
the list will be assessed. All sites will be assessed every time by a
technical and a quality management assessor. Together, the overall
effectiveness of the POCT quality managements system can be
ensured.