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Cen improving quality and safety of healthcare 2013 b
1. IMPROVING THE QUALITY AND
SAFETY OF HEALTHCARE
The Role of the European Service Standards
EN16224 Healthcare provision by chiropractors
Presented by Mr Philippe Druart
Chair CEN/TC 394
Brussels 10.12.2013 -
2. Quality and safety: the cornerstones of
modern healthcare
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Global drive to deliver high standards of healthcare
Economic pressures on health systems
Increasing aging population
Developing technology
Greater burden of disease
Aging population
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3. Need for greater efficiency of healthcare
systems
• Health systems are having to transform under financial
pressure
• New systems must be clinically effective, cost effective
and economically effective
• The traditional model is not working
Brussels 10.12.2013 -
4. Patients’ rights in cross-border healthcare
• EU Directive (2011/24/EU)
• Increasing patient mobility
• Need to standardise provision of health services across
EU member nations
• Safety and awareness of patients must be guaranteed
Brussels 10.12.2013 -
5. Role of European Standards
• Key component of single European market
• Model specification
• Technical documentation to facilitate cross-border trade
and help ensure consistency of services
• Used as the norm in the absence of dedicated legislation
Brussels 10.12.2013 -
6. Development of European standards
Law
Mandatory
Regulations
Standards
CEN Workshop Agreement
Open
Professional good practice, corporate spec., etc.
Brussels 10.12.2013 -
7. Development of European standards
• Open, transparent and consensus-based process
• Represents the agreed view of all interested parties from
participating countries
• Is voluntary but can be a potential legal basis in non
regulated countries
• Automatically transposed in national standards
• Does NOT supersede a national law
• Cannot go over (or further) the content of a national law
• Does NOT supersede a national law Does NOT
supersede a national law Does NOT supersede a national
Brussels 10.12.2013 -
8. Chiropractic: first health profession to have
obtained a Standard
• Reflected an aspiration to improve
standards of patient care
• Driven by quality
• Emphasis on safety
• EN 16224
• Technical Committee: national
standards agencies and
representatives from the chiropractic
profession and educators
Brussels 10.12.2013 -
10. So why have European Standards for health
professionals?
• To objectively measure performance against agree
standards of care and safety
• Sets out service level requirements for the benefit of
patients
• Builds trust and assurance
• Standardised levels of education, training and practice
enhances the consistent delivery of service quality
• Levels out disparities in care provision
• Codifies best practice and the state of the art
Brussels 10.12.2013 -
11. Directive 36 – Modernising the Professional
Qualifications Directive
• Amends Dir. 2005/36/EC on
Recognition of Professional
Qualifications
• Rules allowing EU citizens to
have professional qualifications
recognised across Member
States
• Can only happen at EU level –
role for CEN Standards
• Aims to facilitate mobility of
professionals across member
states
Brussels 10.12.2013 -
12. Main features of modernised Directive
• Introduction of European professional card
• Better access to information and access to e-governmental
services (single contact points)
• Modernises harmonised minimum training requirements
• Sets up an alert mechanism (malpractice and pt safety)
• Common training principles (CEN Standard)
• Mutual evaluation exercises on regulated professions
• Rules on language skills
Brussels 10.12.2013 -
13. Directive 36: Common Training Principles
• Standard for chiropractors reflects provisions of Dir 36
• Recently modernised Directive
• Possibility to set up "common training frameworks" and
"common training tests", offering a new avenue for
automatic recognition.
• Knowledge, skills, competencies needed to pursue a
profession
• Common training framework or test could be set up if the
profession concerned or the education and training
leading to the profession is regulated in at least one third
of the Member States
Brussels 10.12.2013 -
14. Cross Border Directive – 3 main changes
1. Right to choose healthcare and be
reimbursed anywhere in EU even in
private healthcare
2. Prior authorisation for cross border
healthcare exception rather than rule.
3. Right to make informed decisions
about treatment options
Brussels 10.12.2013 -
15. Competing interests: cross border
healthcare and assurance of patient safety
• Patients need to be assured of the status of health
professionals (CEN Standard), whilst recognising
variability of healthcare regulation across the EU
• Where such a disparity of regulation varies, patients must
be assured of their safety through recognised standards of
education, registration, maintenance of professional
standards, complaints and redress – CEN Standardisation
achieves this !
• Regulators must know who they can approach in Member
States where regulation does not exist for information on
education, training and standards (CEN)
Brussels 10.12.2013 -
16. Cross border healthcare – scope of practice
and national restrictions
• Healthcare delivery and scope of
practice varies from one Member
State to another within the EU
• For example, the permitted practice of chiropractors in
one Member State may be illegal in another
• Patients wishing to access care must be informed of
these differences and understand the baseline standard
(CEN)
Brussels 10.12.2013 -
17. EN: Improving quality and safety of
healthcare for patients
• EN must be used in conjunction with new Directives on
RPQ and Cross border healthcare
• EN aids compliance with these new Directives
• Education and clinical training, controlled, validated and
accredited, and a robust Code of Practice must underpin
any CEN standard for health professions
• For example, chiropractic education is validated by an
accreditation agency, the European Council on Chiropractic
Education (ECCE), itself a member of ENQA and EQAR
Brussels 10.12.2013 -
18. Conclusion
• Health matters are the subject of the laws of each
individual Member State.
• The Treaty of Rome recognises only six health
professions of the Specific Sector. Thus any ‘new’
profession must be part of these six, or must remain
unrecognised.
• This anomaly precludes equitable access by patients to
other effective and regulated forms of healthcare.
• CEN Standardisation demonstrates a commitment to
access safe and effective care
Brussels 10.12.2013 -
19. Conclusion
• CEN Standards must not represent aspirational levels of
care, but true, current and factual situations as they relate to
health professions in Europe.
• They must be the level to which all European countries must
reach
• Trust, assurance and safety should characterise the objectives
of CEN Standards in healthcare
• We must be striving to consistently raise the bar!
Brussels 10.12.2013 -
