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    Poct Iso 15895

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    codepalm650
    The document discusses POCT (point-of-care testing) accreditation in Germany based on ISO standards 15189 and 22870. It describes how the DAkkS (German Accreditation Body) uses ISO 15189 as the basis for accrediting medical laboratories, and additionally uses ISO 22870 for laboratories that perform POCT examinations. It also discusses how a guidance document from the EA Laboratory Committee provides policies for accreditation bodies to identify and assess all sites where POCT is performed during an accreditation cycle.

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    Poct Iso 15895

    Uploaded by

    codepalm650
    119 views1 page
    The document discusses POCT (point-of-care testing) accreditation in Germany based on ISO standards 15189 and 22870. It describes how the DAkkS (German Accreditation Body) uses ISO 15189 as the basis for accrediting medical laboratories, and additionally uses ISO 22870 for laboratories that perform POCT examinations. It also discusses how a guidance document from the EA Laboratory Committee provides policies for accreditation bodies to identify and assess all sites where POCT is performed during an accreditation cycle.

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    The document discusses POCT (point-of-care testing) accreditation in Germany based on ISO standards 15189 and 22870. It describes how the DAkkS (German Accreditation Body) uses ISO 15189 as the basis for accrediting medical laboratories, and additionally uses ISO 22870 for laboratories that perform POCT examinations. It also discusses how a guidance document from the EA Laboratory Committee provides policies for accreditation bodies to identify and assess all sites where POCT is performed during an accreditation cycle.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    119 views1 page

    Poct Iso 15895

    Uploaded by

    codepalm650
    The document discusses POCT (point-of-care testing) accreditation in Germany based on ISO standards 15189 and 22870. It describes how the DAkkS (German Accreditation Body) uses ISO 15189 as the basis for accrediting medical laboratories, and additionally uses ISO 22870 for laboratories that perform POCT examinations. It also discusses how a guidance document from the EA Laboratory Committee provides policies for accreditation bodies to identify and assess all sites where POCT is performed during an accreditation cycle.

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    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.

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