Point-of-care testing – a reality
to be dealt with
Report on a seminar on 19 November 2002
Arranged by the Swedish Association
of Health Professionals and the Swedish
Institute for Biomedical Laboratory Science (IBL)
back to report intro
Increasing numbers of laboratories accredited
Accreditation has had a great impact in Sweden in recent years.
The authority responsible is SWEDAC, the Swedish Board for Accreditation
and Conformity Assessment.
SWEDAC is a national accreditation body under the Act concerning
Technical Conformity Assessment. Its accreditation tasks cover laboratories
for testing and calibration, certification bodies for quality systems,
products and staff, accreditation of inspection bodies and EMAS
systems.
Co-operation with authorities, sector bodies and organisations
is as follows:
Formalised contact network with the National Board of Health and
Welfare
Medical Products Agency
Standardisation in health and medical services
Medical Quality Council
The specialist associations in laboratory medicine
Swedish Instrument and Diagnostics Trade Association (SINDIF).
At present, the level of accreditation is 90 per cent for clinical
chemistry, transfusion medicine and clinical microbiology, while
15 per cent of pathology/cytology laboratories and 25 per cent of
primary care laboratories are accredited.
SWEDAC works with various forms of accreditation. It may relate
to individual laboratories such as clinical chemistry at Sahlgrenska
Hospital or several laboratories under the same organisation such
as Huddinge University Hospital. Another form of accreditation relates
to the laboratories of a whole county, such as Värmland Laboratory
Medicine, which covers central hospitals, district hospitals and
primary care laboratories.
With regard to the accreditation of point-of-care activities in
hospitals, the quality systems of the accredited laboratory medicine
unit are also to be applied in the laboratory activity undertaken
in the point-of-care unit, for example internal audits and the handling
of nonconformances and complaints.
The accredited unit is responsible for analytical results from
the point-of-care activity. This means that staff are under the
supervision of the accredited laboratory during the actual analytical
work. The unit is also responsible for method validations, method
descriptions, logbooks, internal and external checks and the issuing
of authorisations for staff.
Accreditation of primary care laboratories covers laboratories
that
organisationally belong to a central laboratory
belong to their own primary care administration
are run privately
Website: www.swedac.se
(This text is based on OH transparencies shown at the seminar by
Marianne Edman-Falkensson of SWEDAC)
Where does responsibility lie in point-of-care testing?:
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