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

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Quality and safety: the cornerstones of modern healthcare• 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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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

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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

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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

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Development of European standards

Regulations

Standards

Professional good practice, corporate spec., etc.

Mandatory

Open

Law

CEN Workshop Agreement

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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 law

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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

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First steps

• Identification of need• Inaugural meeting 01.04.09 (Vienna)• Representatives of national standards agencies,

national chiropractic associations, educators, educational agencies

AENORAFNORBelgiumBSICyprusDanemarkDSIECCEECUFinlandFranceGermanyItalyMc Timony NetherlandsNorwayNISRCUSpainSwedenSINSSC SwitzerlandUK Brussels 10.12.2013 -

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

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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

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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

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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

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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

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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)

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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)

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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

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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

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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!

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Thank you for your attention

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