Working group on POCT

Report
Working group
„ Iceland
„ Italy
„ Norway
„ Spain
„ Sweden
„ Annette Artelt EPBS
Questionnaire from Italy
„ Sent in 2007
„ Evaluated the answers from from:
„ Iceland
„ The Netherlands
„ Sweden
„ Norway
„ Spain
Questionnaire
„ What kind of information is necessary in order
to move forward on this subject?
„ Detailed questionnaire – challenges
„ Lack of regulations
„ Diversity within countries
Questions sent to members before this
meeting
„ Policy regarding POCT
„ Implementation of ISO standard 22870:2006
„ Certification of POCT instruments
Policies received
„ IBMS United Kingdom
„ AMLS Ireland
„ LabMed Switzerland
„ Australia
„ Sweden
„ Norway
ISO 22870:2006 Point-of-care testing (POCT) --
Requirements for quality and competence

„ ISO 22870:2006 gives specific requirements

applicable to point-of-care testing and is
intended to be used in conjunction with
ISO 15189. The requirements of ISO
22870:2006 apply when POCT is carried out
in hospital, clinic and by a healthcare
organization providing ambulatory care.
„ Patient self-testing in a home or community
setting is excluded, but elements of ISO
22870:2006 can be applicable.
Implementation of ISO 22870
„ Work just starting in most countries
Certification of POCT instruments
„ IVD Directive
„ HMS regulations
„ Description of the instrument
„ No regulation of the sensitivity and specificity
of the Analyte
Certification of POCT instruments
„ UK: Guidance Notes from the Medicines and
Healthcare products Regulatory Agency
„ The Dutch Healthcare Directorate
Certification of POCT instruments
„ Scandinavia: The Scandinavian evaluation of
laboratory equipment for primary health care (SKUP)
„ SKUP gathers information about laboratory
instruments intended for use in primary care, as well as
organising assessment of such instruments
„ The goal of SKUP is to produce objective and
independent information concerning the quality and
user-friendliness of laboratory equipment for
physicians' offices outside the hospital
Continuing work
„ Focus on the quality and the performance of
the tests
„ What kind of tests should be used
„ Requirements for quality of instruments
„ Requirements of competence
„ Questionnaire?
Common policy
„ Question from IFBLS:
„ Common policy for IFBLS and EPBS?