Presentation outlining the working group's analysis of issues regarding the implementation of POCT directives and the certification of POCT instruments. Work continues to work on issues and develop a common policy. http://www.epbs.net/bratislava/index.htm

1. Working group on POCT
Report

2. Working group
Iceland
Italy
Norway
Spain
Sweden
Annette Artelt EPBS

3. Questionnaire from Italy
Sent in 2007
Evaluated the answers from from:
Iceland
The Netherlands
Sweden
Norway
Spain

4. Questionnaire
What kind of information is necessary in order
to move forward on this subject?
Detailed questionnaire – challenges
Lack of regulations
Diversity within countries

5. Questions sent to members before this
meeting
Policy regarding POCT
Implementation of ISO standard 22870:2006
Certification of POCT instruments

6. Policies received
IBMS United Kingdom
AMLS Ireland
LabMed Switzerland
Australia
Sweden
Norway

7. 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.

8. Implementation of ISO 22870
Work just starting in most countries

9. Certification of POCT instruments
IVD Directive
HMS regulations
Description of the instrument
No regulation of the sensitivity and specificity
of the Analyte

10. Certification of POCT instruments
UK: Guidance Notes from the Medicines and
Healthcare products Regulatory Agency
The Dutch Healthcare Directorate

11. 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

12. 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?

13. Common policy
Question from IFBLS:
Common policy for IFBLS and EPBS?