CERTIFICATION MANUAL FOR HEALTHCARE ORGANISATIONS .CERTIFICATION MANUAL FOR HEALTHCARE ORGANISATIONS
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Haute Autorit de sant, 2 avenue du Stade-de-France 93218 Saint-Denis-la-Plaine Cedex Tl. : 01 55 93 70 00 www.has-sante.fr
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HAS Direction de lAmlioration de la Qualit et de la Scurit des Soins 2/120 Manuel de certification dition novembre 2008
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PREFACE The procedure for the certification of healthcare organisations, which was introduced into the French healthcare system by order No. 96-346 of 24 April 1996 on hospital reform, aims to provide an independent assessment of the quality of services in an establishment. The certificate process is now part of the reality of French healthcare: - certification has allowed the approach to quality to be boosted and made sustainable; - the certification visit is a key period in the life of the healthcare establishments. The 2010 version represents a significant change in the certification process. The aim is to offer to the healthcare system a mechanism that provides a relevant and balanced response to the expectations of users, healthcare professionals and the public authorities: - certification must provide accessible and clear information to users; - its own position as an internal management tool for the establishments must be strengthened; - it must create the conditions under which healthcare professionals wish to act; - it must finally play a role in regulating quality in healthcare organisations. Results of the certification must become an essential element for understanding the quality of
the establishments. Certification V1 aimed to start the process, V2 provided for the medicalisation of the process, while the new system has been thought up and developed to implement a certification system that is both ongoing and efficient. Laurent Degos Franois Romaneix Chairman of the Haute Autorit de Sant Director of the Haute Autorit de Sant
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INTRODUCTION 1 - The development of a certification system covered by the V2010 The certification procedure, which is now part of the reality of French healthcare, must respond to numerous expectations from its environment. Within the framework of the development of the 3rd version, the Haute Autorit de Sant wishes to carry out an important reorganisation, with three main concerns in mind: - to learn lessons from the critical feedback noted during the actual operation of the second version of the procedure; - to make the approach suitable for an environment that has changed significantly; - to take into account the processes used in accreditation systems in other countries. The new manual has been drafted with a view to concentrating, during the certification process, on the main levers and on those elements that enable quality and safety of care in healthcare establishments, within a context that is characterised by: - legitimate claims expressed by users; - overexposure of professionals to excessively formal external procedures; - demographic difficulties which are encountered by a very large number of professionals; - budgetary constraints in the healthcare system. a) The positioning of V2010 certification The preparatory V2010 work and feedback from experience in the previous versions have demonstrated the need to bear in mind and clarify the positioning of the certification. This positioning is characterised by three main elements:
1. HAS certification is a certification of an establishment as a whole and not a certification for each one of the areas of activity that make up a healthcare establishment:
The system that has been set up (general frame of reference, non-comprehensive visit, generalist surveyors) relates to the overall operation of the establishment and does not aim to analyse the operation of each area of activity in precise detail.
2. Certification has two complementary aims. It evaluates both:
o implementation of a management system for the establishment, including whether or not a process is in place to improve the quality and safety of
healthcare; o whether the establishment has achieved a level of quality which is based on specific criteria that are deemed to be essential. For this reason, HAS has
endeavoured to improve its methods of evaluation to allow for reproducible measurement of quality in critical areas through the definition of "required priority practices" (RPP) (see below).
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Both of these objectives have been the subject of further developments. They aim to establish a renewed and reinforced set of requirements, which will be expressed through a process of grading and decision-making using a narrow frame of reference. There will undoubtedly be situations in which HAS will be called upon to declare that healthcare establishments have not been certified.
Certification still promotes the "learning process, but it is not a simple supportive educational measure for healthcare establishments. It provides an assessment of the quality of an establishment, where expectations of users, professionals and public authorities intersect.
3. Certification is a measure that helps to regulate the quality of healthcare establishments. The approach proposed within the framework of V2010 attaches great importance to the idea that the decision to grant certification should be more firmly anchored to mechanisms of regulation of hospitals by reinforcing the requirements for coherence between the efforts required by the Hospitalisation and Healthcare Organisation Department (DHOS), the Regional Hospitalisation Agencies (ARH) and HAS, where the concern is to implement quality criteria and to analyse quality indicators. More fundamentally, and without giving up the principle of independence of the decision-making process for the certification of healthcare establishments, the aim is to integrate the certification procedure into context, before the visit (through the more systematic use of other available evaluation work and results) and after it (by insuring that certification decisions be considered in discussions between the healthcare establishments and the regional hospitalisation agencies leading to the definition of multi-annual contracts concerning objectives and resources).
b) General objectives pursued when developing V2010 Four general objectives have guided the development of V2010:
1. To reinforce the procedures efficiency in terms of improving healthcare quality and safety;
2. To simplify the certification process by reducing the workload and formal requirements;
3. To increase the guarantee provided to users;
4. To include certification and the issue of quality of care in the hospital regulation process. 2 V2010 certification manual This document contains the reference framework, criteria and assessment elements from version 2010 of the certification. This manual, drafted thanks to the work of groups made up of healthcare professionals, experts and users representatives, has been re-read by the various stakeholders and institutions involved in the certification of healthcare establishments.
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a) The structure of the manual The chosen structure of the manual is: - a two-chapter structure
- chapter I: Management of the establishment - chapter II: Patient care
HAS has chosen to focus on the evaluation of management systems and has simplified the structure of the manual by avoiding redundancy between the requirements relating to the definition of policies and those relating to the implementation and evaluation of those policies.
- organisation of the items to be evaluated according to stages in a process of improvement.
To improve the readability of the manual and provide a structure for the grading system, each evaluation item in V2010 is grouped into three columns, E1, E2 and E3. E1, E2, E3 correspond to the stages usually found in an improvement plan: anticipate, implement, evaluate, improve.
Column E1 E2 E3
Stage Anticipate Implement Evaluate and improve
Type of item to be evaluated
Define a policy, organise an activity, define an action plan, etc.
Carry out an activity, meet requirements, implement an action plan, train, raise awareness, etc.
Evaluate the activity, implement improvement action plans, ensure these plans are effective, etc.
This organisation of the items to be evaluated facilitates the understanding by users (professionals in establishments, surveyors) of the manual and of the requirements of each criterion. The level reached by the establishment in the various evaluation items enables each criterion to be graded using one of 4 grades: A, B, C and D; these correspond to an assessment of the level of quality attained by the establishment for this criterion.
b) Progress by area
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