Principes méthodologiques pour la gestion des risques en établissement de santé - janvier 2003 - Principles of risk management in healthcare organisations - january 2003

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Description

Posted on Jan 15 2003 Healthcare organisations (HCOs) have to deal with many risks that threaten patient safety. This guide is based on current experience in several sectors. It describes the concepts and principles underlying risk management and the key factors in dealing with risk. Risk management has both managerial and technical aspects, and can reduce risks for patients. This guide will be particularly useful to professionals involved in the French HCO accreditation procedure and who wish to introduce a risk management programme in their HCO. Healthcare organisations (HCOs) have to deal with many risks that threaten patient safety. This guide is based on current experience in several sectors. It describes the concepts and principles underlying risk management and the key factors in dealing with risk. Risk management has both managerial and technical aspects, and can reduce risks for patients. This guide will be particularly useful to professionals involved in the French HCO accreditation procedure and who wish to introduce a risk management programme in their HCO. Posted on Jan 15 2003

Sujets

• Méthodologie
• Médecine

Informations

• Publié par: haute-autorite-sante-qualite-et-securite-soins
• Publié le: 01 janvier 2003
• Nombre de lectures: 43
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: Français

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Methodology guide

 

 

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January 2003

 

This publication by theHaute Autorité de santé the former (HAS) was produced by ANAES, French Agency for Accreditation and Evaluation in Healthcare, now part of HAS. It was validated by ANAES’ Scientific Council.

 

 

Principles of risk management in healthcare organisations  

For further information (in English): Erbault M, Glikman J, Ravineau MJ, Lajzerowicz, Terra JL. Promoting quality improvement in  French health care organisations: Design and impact of a compendium of models and tools. Qual Saf Health Care2003;12:372-376.  

For further information (in French only): Mise en place d’un programme d’amélioration de la qualité(Implementing a quality improvement programme) (ANDEM,1996) Accreditation manual for healthcare organisations(ANAES, 1999; revised 2004) Méthodes et outils des démarches qualité pour les établissements de santé (Methods and tools for quality initiatives in healthcare organisations) (ANAES, 2000) Démarches qualité des établissements de santé: principes de recours à un prestataire (Quality initiatives in HCOs: principles of using consultants) (ANAES, 2001) Construction et utilisation des indicateurs dans le domaine de la santé: principes généraux ( 2002)General principles of constructing and using health indicators) (ANAES, Principes de mise en œuvre d’une démarche qualité en établissement de santé  (Principles of implementing a quality initiative in an   HCO(ANAES, 2002)  Préparer et conduire votre démarche d’accréditation(Preparing for and carrying out an accreditation initiative in your organisation) (ANAES, 2002)  

All rights of translation, adaptation and reproduction by any means, are reserved, for all countries. Any reproduction or representation of this work, in whole or in part, by whatever means, made without the permission of ANAES is illegal and constitutes an infringement of copyright. In accordance with the provisions of the Intellectual Property Code, only the following are permitted: 1) reproduction which is strictly for the purpose of the private use of the person making the copy and not intended for collective use, and 2) quotation of short passages which are justified as being for purposes of a scientific nature or for illustration of the work in which they are incorporated.   This document was produced in January 2003. It may be ordered from:   Haute Autorité de santé (HAS) - Service Communication 2 avenue du Stade de France – 93218 Saint-Denis La Plaine CEDEX – France. Tel.: [phone] – Fax: [phone]   tn.erf//ww.washttp:        

  © 2003. Agence Nationale d'Accréditation et d'Évaluation en Santé (ANAES)

ANAES/January 2003 - 2 -

 

  F OREWORD  

Principles of risk management in healthcare organisations  

    Certain areas related to quality improvement in healthcare organisations (HCOs) generate considerable practical, strategic and media interest. Risk management is one of these, and this document reflects ANAES' concern with improving patient safety. The production of clinical practice guidelines since 1990, the implementation of quality improvement programmes between 1995 and 1997 in areas related to patient safety, and the introduction of an accreditation system in 1996, are all instances of this concern. From the outset, the accreditation procedure established standards and criteria for risk prevention. By introducing the procedure, ANAES contributed to a better understanding of quality and safety in HCOs, and helped to establish goals and design tools for bringing about improvements. ANAES has tested methods and published guides (eg on professional practice appraisal (1995), developing quality assurance programmes (1997), quality assurance tools and methods (2001), and the principles of implementing a quality initiative in  an HCO (2002)). The main aim of this document is to present educational, technical and strategic information, as well as descriptions of experience in other industries that will help in understanding risk management. Although the organisation of HCOs is complex, HCOs nevertheless have a responsibility to implement risk prevention and management programmes. ANAES will build on their observations and experience and work in partnership with HCOs to further practical knowledge of risk management. It is hoped that this document will contribute to this aim.  

 

Alain Coulomb Executive Director  

 

ANAES/January 2003 3 --

 

Principles of risk management in healthcare organisations  

  C ONNTTES     Foreword Contents Introduction   Section 1 The concept of risk and the aims of risk management I. The concept of risk II. Risk and human activity III. Voluntary and involuntary risk-taking IV. Concept of acceptable risk V. Risk management and risk acceptability VI. Aims of risk management   Section 2 Complex systems and their failures I. Complexity of manufacturing systems II. Types of failure in a complex system III. Technical failures IV. Human error V. System failures related to the concept of deviance

3 4 6

8 8 8 8 8 9 10 10

12 12 12 13 14 15 17

VI. System failures related to the organisation 18   Section 3 20 Risk control 20 I. Risk identification 20 I. 1 Identifying risks before an event (a priori) 20 I.2 Identifying risks after the event (a posteriori) 21 II.   Risk analysis   III. Response to risk 25 IV. More about the concept of defences in depth 29   Section 4 32 Risk management 32 I. Starting the initiative 32 II. Programme structure 35 III. A risk management programme 36 IV. Programme monitoring 37 V. Anticipated results 37 VI. Implementing a crisis management system 38   Section 5 41 Approaches to risk in healthcare organisations 41 I. Risks in HCOs 41 II. Published data on risks for patients – Risks related to clinical and care activities 42   Conclusions and future action    

ANAES/January 2003

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46

Annexes  

 

Principles of risk management in healthcare organisations  

  Annex 1:Review of papers on systems for declaring incidents or accidents in HCOs Annex 2:and risk management at Air FranceFeedback Annex 3:Morbidity and mortality meetings: literature review Annex 4:Conducting an analysis and investigation after a serious incident or accident Annex 5:Preventive measures based on ranked defences-in-depth Annex 6:the quality system, professional practice appraisal andContribution of accreditation to risk management   Glossary List of abbreviations References Acknowledgements

ANAES/January 2003

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49 54 56 59 64

65  

67 70 71 78

 

Principles of risk management in healthcare organisations  

  I TNORIONDUCT  

 

What is risk?

The very nature of an HCO means that it has to deal with risk. To tackle disease, HCOs implement actions for the benefit of patients. The anticipated benefit is the justification for the action undertaken. However, this action may have harmful consequences. The potentially harmful consequences that accompany the attempt to bring benefit constitute the risk.

Severity of risks in HCOs

Although scientific and technological advances have generated considerable improvements in the clinical effectiveness of patient care, this gain in effectiveness has led to new risks. International data bear witness to the severity of these which have not yet been completely mastered. For example, in the United States, the number of deaths due to medical error is estimated to be between 40 000 and 100 000 a year (Institute of Medicine, 2000). In comparison, road accidents in the United States kill 35 – 40 000 people a year. The safety of individuals is therefore a major challenge for HCOs.

Initiatives to control risk

Many professional, managerial and regulatory initiatives have been undertaken in HCOs, in an attempt to control identified risks. They have usually focused on a specific area (risk of fire; malicious action; drug-related, nosocomial and transfusion risks; risk to staff). They have involved many stakeholders within the HCO such as managers, nursing staff, doctors, engineers, legal experts, occupational medicine units, the Committee for hygiene, safety and working conditions (CHSCT), and inspection bodies. Professional practice appraisal, quality initiatives, accreditation, formal vigilance systems and initiatives focusing on certain types of risk (eg controlling nosocomial infection) are all designed to improve the quality of care, making safety a priority.

What is needed?

The above approach has led to piecemeal risk management in HCOs. Risk is hard to control when there is no all-embracing view. Some risks are regarded as a high priority (eg transfusion risk), while others are given little attention despite their seriousness (eg drug- related risk, iatrogenic risks of medical procedures and care). The aim of risk management is to reduce all risks that might occur (risk to individuals, legal risk, financial risk). For organisations whose activities generate a major risk to individual safety, the main aim of risk management will be to ensure the safety of individuals.

Aim of this guide

Risk management has contributed to substantial advances in safety and has reached a stage of maturity in a number of industries, even though risk persists and accidents sometimes occur. Some recent risk management initiatives that have been implemented in HCOs have drawn on experience gained in industry.

ANAES/January 2003

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Principles of risk management in healthcare organisations  

This guide describes the concepts of risk management that apply to an HCO. It is intended first and foremost for people working in HCOs (managers, clinicians, nursing staff, other professionals). The guide: · adopts a global approach to risk management and pays special attention to risk for the patient, particularly through the examples chosen; · on the principles, concepts and structures of risk management. Thesefocuses principles have to become part of an HCO’s culture before it can use the tools of risk management; · is a contribution to the development of risk management. Suggestions from professionals in HCOs will be used to expand on the methods put forward. Moreover, readers are invited to send their comments to ANAES 1  further this exchange of to ideas.

                                                 

1 ANAES: French National Agency for Accreditation and Evaluation in Healthcare (now part of HAS)

ANAES/January 2003

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Principles of risk management in healthcare organisations  

  Section 1 T HE CONCEPT OF RISK AND THE AIMS OF RISK MANAGEMENT  

I.

T HE CONCEPT OF RISK  

In everyday language, the term ‘risk’ has several meanings. This guide uses the following definitions: · an unwanted situation having negative consequences resulting from one or more events whose occurrence is uncertain; · any feared event which reduces the hope of gain and/or efficacy in human activity.

II.

R ISK AND HUMAN ACTIVITY  

Risk is part of life and inherent to all human activity. There are two main aspects to risk-  taking: · Risk-taking is an attempt to gain benefit from an activity. Treating appendicitis by appendectomy makes it possible to avoid peritonitis and death, but requires surgical and anaesthetic risks to be taken.

·  

Risk-taking is often a factor in performance; it can help improve performance. Myopia can be treated with corrective lenses. Surgery for myopia aims for greater benefit, but involves taking a procedure-related risk. In the treatment of acute leukaemia, bone marrow transplantation may be more likely to achieve remission than classic chemotherapy, but it carries an increased risk related to the severity and duration of aplasia.

In healthcare, the search for long-term benefit often means taking a short-term risk.

III.

V OLUNTARY AND INVOLUNTARY RISK - KINGTA  

In order to manage risk, a distinction has to be made between voluntary and involuntary risk- taking: · voluntary risks are taken in medicine when treating patients or enhancing treatment. Deciding to use a chemotherapy protocol which is more powerful but which has more side-effects, to increase the chance of cure.

 ·

involuntary risk-taking involves exposure to unknown or unforeseen risks. Wrong dose or drugs given during chemotherapy.

  Risk mana ement assumes that existin voluntary risk-taking from imposed risk.

 risks have been identified b distin

ANAES / January 2003

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