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Clinical Risk Management Systems 1

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The document discusses recommendations for minimum requirements of clinical risk management systems in hospitals.

Clinical risk management comprises strategies, structures, processes, methods and activities to support safe patient care by recognizing, analyzing, assessing and handling risks.

Risk management aims to increase safety, serves quality management, is part of decision making, and addresses risks in prevention, diagnosis, treatment and nursing care.

RECOMMENDATION

Risk
and Ma
lity licy Stra nage
a o teg me
Qu isk P ponsibilit y
R Res ies

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us t Re
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uo en
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ou
Dev ntin
Identification

rce
p
elo
Co

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Competence/
Evaluation
Reporting

Expertise
Risk Analysis
Management
Principles

Treatment
Co

Assessment

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mm

un nn a
ic a Pl
tio
n
Participa ti o n

Safety Culture

Requirements on Clinical
Risk Management Systems
in Hospitals
Table of Contents

Preface 4
Risk Management Principles 5
Clinical Risk Management
Clinical Risk Management System 5
Risk Policy and Risk Management Strategy 6
Responsibilities 6 Clinical risk management in hospitals and rehabilitation clinics comprises the
Resources 7 totality of the strategies, structures, processes, methods, instruments and activi-
Competence/Expertise 7 ties used in prevention, diagnosis, therapy and nursing care, that support staff
Planning 7 at all levels, functions and professions in recognising, analysing, assessing and
Participation 8 handling risks in patient care, so that the safety of patients, of those involved in
Communication 8 their care and the organisation itself is increased.

Reporting 8
Continuous Development 9
The Risk Management Process 9
Risk Identification 9
Risk Analysis 10
Risk Assessment 10 Safety Culture
Risk Treatment 10
Evaluation 10
Glossary of Clinical Risk Management 11 Safety culture, in the context of clinical risk management in hospitals and re-
Methods and Tools for Risk Management 13 habilitation clinics, describes the manner in which safety is organised in the
Proactive methods 13 context of patient care and thus reflects the attitudes, convictions, perceptions,
values and conduct of management and other staff with respect to the safety of
Proactive tools 15
patients, staff and the organisation itself. Safety culture can be developed and
Reactive methods 15
is subject to a constant learning process.
Reactive tools 16
List of abbreviations used 17
References 18
Feedback/Publication details 19

2 3
Foreword Risk Management Principles Clinical Risk Management System
Risk
and Ma
ty y Stra nage
ali olic
The management of clinical risks in hos- This recommendation is meant to enable Qu isk P
R Resp
onsibilities
teg me
y Clinical risk manage- The administrative, medical and nursing top

nt
us t Re
s
uo en
pitals and rehabilitation clinics reveals in- administrative, medical and nursing man- m ment in hospitals and management in hospitals and rehabilitation

ou
Dev ntin
Identification

rce
p
elo
Co

s
creasing importance within recent years. agement staff, risk managers and risk own- rehabilitation clinics: clinics ensures the setting up and mainte-

Competence/
Evaluation

Reporting

Expertise
Risk Analysis
Management

Based on the findings of research conducted ers/persons responsible for the risk to adapt nance of a clinical risk management system
Principles

Treatment

Co
Assessment
in the field of critical error avoidance, risk already existing or emerging risk manage- (CRMS) by:

in g
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a
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tio n
n
Participatio
management has been established as a core ment systems according to need.
Safety Culture
task of management in securing the contin- a) drawing up and communicating a risk
ued existence of organisations. This recommendation takes a meta-level 1. aims to increase the safety of patients, per- policy and risk management strategy,
approach and consequently contains no de- sons involved in their care and the organi- b) defining goals for the CRMS,
Besides business risk management policies tailed roadmap of measures or individual sation itself, thereby creating and protect- c) providing the necessary resources for
in healthcare facilities, which are wide- checklists, as the conception of the man- ing value, CRMS,
spread as they are based on statutory pro- agement system has to be adapted to the 2. serves, together with quality management, d) planning the CRMS,
visions, the systematic and comprehensive specific context of the individual facility or for the organisation‘s development, e) specifying responsibilities within the
preoccupation with clinical risks via clinical institution. 3. is part of the decision-making process in CRMS,
risk management is gaining importance in the context of providing care for patients, f) designing a measurement system to de-
the health care system. This recommendation was read and com- 4. addresses clinical risks in connection with termine the efficacy of the CRMS, and
mented on prior to publication by numer- prevention, diagnosis, treatment and nurs- g) creating a safety culture built on the
The Federal Joint Committee (G-BA) has ous experts and practitioners from various ing care, CRMS.
been commissioned with the task of speci- professional fields. We wish to thank all of 5. is systematic, structured, prioritised and
fying minimum standards for clinical risk the commentators for their most valuable tailored to the needs of the individual or- The administrative, medical and nursing top
management systems in hospitals. However, contributions. ganisation, management in hospitals and rehabilitation
so far, it is unclear which preventive meas- 6. is based on the best available information, clinics ensures that the CRMS is coordinated
ures must be included in the minimum re- Your German Coalition for Patient Safety figures, data, facts and scientific findings, and compatible with the quality manage-
quirements placed on such a system. (Aktionsbündnis Patientensicherheit) 7. fosters inter-professional and inter-discipli- ment system, other management systems,
nary communication, as well as with the organisation‘s policies
The German Coalition for Patient Safety (Ak- 8. takes into account the patient‘s social, cul- and strategies.
tionsbündnis Patientensicherheit—APS) set tural and individual environment and that
up a working group on this topic to recom- of persons involved in their care, The top management assures that the rel-
mend minimum requirements for clinical 9. creates target group oriented transparen- evant statutory and sub-statutory require-
risk management systems in hospitals and cy, ments are fulfilled by the organisation.
rehabilitation clinics. 10. reacts to developments in medicine and
nursing care, as well as to health-related
economic and demographic changes.

4 5
Risk
and Ma
ty y Stra nage
ali olic teg me
Qu isk P onsibilities y
R Resp

nt
us t Re
s
uo en
m ou
Risk Policy and Risk Management Strategy are regularly identified, analysed, assessed, aggregate and analyse the information glea-
Dev ntin

Identification rce
p
elo
Co

s
Competence/
Evaluation
treated, evaluated and reported. ned from these sources within a reasonable
Reporting

Expertise

Risk Analysis
Management
Principles

Treatment Organisations supple- a) the demand for healthcare, timeframe.


Co

Assessment
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ment their policies b) the state of the art and development Furthermore:
nn

a
ic a Pl
tio n
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Participatio

Safety Culture
with input from clini- trends in medicine, nursing and technol- a) At least one qualified risk manager must If necessary, suitable internal and external
cal risk management ogy, be appointed, experts will be consulted.
(CRM) and use this input to draw up a risk c) clinical risks related to the particular lo- b) Persons responsible for the risk must be
management strategy. cation, designated. Planning
d) the economic situation,
The risk management strategy lays down e) health policy as well as statutory and sub- Resources Based on the risk policy and risk manage-
specifications regarding the following as- statutory requirements that affect the ment strategy, hospitals and rehabilitation
pects: CRM, Hospitals and rehabilitation clinics provide clinics integrate:
a) linkage of the organisation‘s goals, par- f) the status, expectations and values of cur- sufficient resources (personnel and equip- a) the risk management process into exist-
ticularly economic and safety-related rent and future personnel, ment), to achieve the goals laid down in the ing management processes and, where
goals, g) the values, approaches and interests of risk management strategy. necessary, into additional management
b) provision of the resources necessary to the cross sectoral partners in care provi- processes that are to be defined,
implement the risk management system sion, To this end, in particular: b) effective and appropriate prevention
(persons, budget, necessary equipment), h) the approaches of suppliers and other a) The risk manager and the persons re- measures in all of the performance and
c) risk-related responsibilities in organising service providers. sponsible for the risk must have to be supporting processes relevant to the
both the setting up and the running of qualified, CRM.
the system, The risk policy and risk management strat- b) Training programs must be implemented
d) the way in which the evaluation is con- egy are communicated appropriately. within the framework of the statutory To this end, a risk management plan will be
ducted to determine the efficacy of the and sub-statutory requirements, drawn up, and will be an integral compo-
CRMS, and
Risk
Ma
c) Resources must also be made available to nent of the organisation‘s entire planning
ty y Stra nage
e) the way in which the findings of the ef-
ali olic
Qu isk P
R Resp
onsibilities
teg me
y Responsibilities conduct measures to treat risks. process.
nt

us t Re
s
uo en
ficacy evaluation are reported, m
ou
Dev ntin

Identification
rce
p
elo
Co

f) evaluation and further development of Hospitals and re- Competence/Expertise Based on the risk management plan, the fol-
Competence/

Evaluation
Reporting

Expertise

Risk Analysis
Management
Principles
the risk policy and risk management Treatment
habilitation clinics lowing steps will be taken at specified inter-
Co

Assessment
in g

strategy, including frequency, content expand the existing Hospitals and rehabilitation clinics possess vals:
mm

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ic a Pl
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Participatio
and evaluation criteria. initial organisation the competence to select and use suitable a) risk analyses will be conducted,
Safety Culture
by adding CRM as- methods for the identification, analysis, as- b) the policy, goals and strategies will be
In order to incorporate the principles speci- pects. A member of the top management sessment, treatment and evaluation of risks. analysed with a view to minimising risk,
fied in the risk policy into a risk manage- has full responsibility for the development, c) the material/immaterial resources, as
ment strategy, the context that is relevant implementation and maintenance of the This comprises the competence to define well as the existing knowledge will be as-
to the CRMS needs to be analysed. This in- CRM. This includes, in particular, respon- the internal and external sources of infor- sessed in relation to risk,
cludes: sibility for ensuring that the clinical risks mation that are relevant to the CRM and to

6 7
d) the information systems, information need for their active involvement in CRMS, Reporting agement strategy and the risk management
flow and decision-making processes will whether in the form of the notification of plan are to be further developed.
be assessed in relation to risk, critical events, collaboration in the analysis Hospitals and rehabilitation clinics are
Risk
e) the safety culture will be evaluated from of potential causes, or the implementation called upon, within the framework of stat- ty
and
ali olic
Qu isk P
y
esponsibilities
Ma
Stra nage
teg me
y
The Risk
Management
R R

nt
the perspective of the patient, those in- of preventive measures. utory-official requirements, to inform in- us
uo ent
Re
s

ou
m

Dev ntin
Identification

rce
p
Process

elo
Co
volved in providing care and any other ternal and external agencies regarding the

s
Competence/
Evaluation

Reporting

Expertise
Risk Analysis
executive staff, In the process, employees have a key role status, modifications to and the efficacy of Management
Principles

f) the implementation of external guide- to play in the identification of clinical risks, the CRMS. Treatment
The risk manage-

Co
Assessment

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lines, requirements and models will be both in their role as individuals and in their tio
n
Participatio
n ment process ge-
assessed for resulting internal risks, function as members of professional and If appropriate hospitals and rehabilitation Safety Culture nerically describes
g) existing cooperation schemes and the interdisciplinary teams of care. clinics will aggregate comparable individ- the procedure for
services they produce will be examined ual risks from several areas, or from differ- handling risk and is broken down into the
for clinical risks; the same goes for servic- Communication ent methods and instruments, to arrive at following steps: identification, analysis, as-
es that the facility itself provides for third an overall assessment of the specific risk to sessment, treatment and evaluation.
parties within the framework of coopera- Hospitals and rehabilitation clinics inform which the hospital is exposed.
tion schemes. everyone who is involved in patient care on Risk Identification
the status and results of the CRMS and the As a confidence building measure, hospitals
Participation resulting changes, on a regular basis and us- and rehabilitation clinics will report on their Hospitals and rehabilitation clinics identify
ing content that is appropriate to the target management of clinical risks. The recipients the risks that have the potential to harm pa-
Hospitals and rehabilitation clinics will in- group. of this information will be especially: pa- tients, those persons involved in providing
form and train those involved in providing tients, relatives and inter-sectoral partners patient care or the organisation itself.
care to patients regarding the need for a Furthermore, the degree and frequency in healthcare provision. The information is
CRMS and the necessary methods and in- with which communication on clinical risks to be prepared in such a way as to be target- Risk identification is conducted taking into
struments that have been introduced for is to take place—and with which interest group oriented and, where necessary, will account the context that is relevant for the
this purpose. groups—will be specified. This includes, in be examined to ensure comprehensibility. CRMS. In this process, special consideration is
particular, the intersectoral interfaces. to be given to patient’s perspective.
For different target groups, educational Continuous Development
interventions/training that is appropriate— Within their crisis management framework, The risk identification takes into account:
timewise, as well as in terms of content and hospitals and rehabilitation clinics have The administrative, medical and nursing top a) notifications from reporting and learn-
language skills—are to be planned and con- written regulations on how to communicate management in hospitals and rehabilitation ing systems, especially the Critical Inci-
ducted. This training is to be repeated if nec- in a crisis situation. The persons designated clinics assess the clinical risk management dent Reporting System (CIRS),
essary and adapted to possible changes in in the communication plan are to be in- system systematically and regularly, accord- b) events that have caused harm to patients,
the system. structed with respect to their roles. ing to the organisation‘s needs. c) liability cases,
d) occupational accidents,
A key element of educational interventions/ The results will serve as a basis for taking de- e) complaints,
training is making employees aware of the cisions on how the risk policy, the risk man-

8 9
f) external risks or instances of harm that Risk Treatment Glossary of Clinical Risk Management
have been made public,
g) national and international recommenda- Risk treatment includes all of the measures Risk In the context of clinical risk management, risk is defined as
tions for action on patient safety, agreed upon for treating identified, ana- an uncertainty in the provision of patient care that, with a
h) survey results, lysed and assessed risks. The following op- projected likelihood of occurrence and a projected impact, is
i) statistics on complications, tions are available for handling risk: capable of causing harm to patients, to the persons involved
j) results of audits and inspections. l Avoiding the risk by terminating the ac- in their care and/or to the organisation itself.
tivities in question, Clinical Risk Clinical risk management in hospitals and rehabilitation
All relevant identified risks are to be docu- l Reducing the risk by means of preventive Management clinics comprises the totality of strategies, structures, proc-
mented and assigned to the person respon- measures and/or esses, instruments and activities in the fields of prevention,
sible for the risk. l Transferring the risk until an acceptable diagnostics, treatment and nursing care that support staff
level of residual risk is achieved, members at all levels, in all functions and in all professional
Risk Analysis l Accepting the risk with supervision, and groups in recognising, analysing, assessing and handling
l Accepting the risk without additional su- risks in the provision of care, thereby increasing the safety
The goal of the risk analysis is to determine pervision. of patients, those who care for them and the organisation
itself.
the causes of risks and factors that favour
errors, the likelihood that such errors will Risk handling is conducted on the basis of Risk Policy Risk policy formulates principles or guidelines for basic han-
occur, as well as their effect on the safety the PDCA Cycle and must take statutory dling, not only of risks but also of opportunities. It forms the
of patients, persons involved in providing and sub-statutory requirements, including external framework for the implementation of a risk man-
healthcare and the organisation itself. recommendations for action by external ex- agement system and is the foundation of a risk management
perts, into account. strategy.
If sufficient information cannot be gathered Risk Management Risk management strategy describes the implementation of
with one method of risk analysis, it might Evaluation Strategy principles specified in the risk policy. To this end, the com-
become necessary to apply additional meth- ponents, methods and tools of risk management come into
ods of analysis or to consult additional ex- Within the framework of the evaluation, it play.
perts. will be ascertained whether the procedure Risk Management A risk management system is described as the entirety of
stipulated for risk handling achieved the System components, methods and tools that are related or linked to
Risk Assessment desired goal. If the desired goal was not each other in such a way that the organisation is placed in
reached, alternative options for treating risk a position to identify and permanently reduce the relevant
Within the context of risk assessment, deci- must be taken into consideration. clinical risks with a view to enhancing patient safety.
sion-makers determine, on the basis of iden- Person responsible for the Every risk is clearly assigned to a so-called “person respon-
tified and analysed risks, which risks are risk (= risk owner) sible for the risk” who has the responsibility and authority
treated with what intensity and priority. to take action with respect to this specific risk. The person
responsible for the risk makes an assessment of identified
risk on a regular basis, identifies potential risk minimisation
measures and ensures that they are effectively implemented.

10 11
Risk Manager Risk manager is responsible for and has the methodical ex- Methods and Tools for Risk Management
pertise to coordinate the clinical risk management system.
This means especially observing and assessing the planning Clinical risk management methods are sys- ods and tools can be used in the absence of
and implementation of measures. tematic, reproducible procedures that are a certain event, whereas reactive methods
Management Assessment Assessment of the clinical risk management system accord- suitable for identifying, analysing and assess- and tools must always be preceded by an
ing to the requirements laid down in DIN EN ISO 9001 [1]. ing risks and generating measures to treat event if they are to be applied.
these risks. Tools, on the other hand, support
Safety Culture Safety culture, in the context of clinical risk management in
parts of the risk management process. What all methods have in common is the
hospitals and re­habilitation clinics, describes the manner in
which safety is organised in the context of patient care and fact that they can only be fully effective
thus reflects the attitudes, convictions, perceptions, values A distinction is made between proactive and within the organisation if they are based on
and conduct of management and other staff with respect to reactive methods and tools. Proactive meth- an effective measures management system.
the safety of patients, staff and the organisation itself. Safety
culture can be developed and is subject to a constant learn-
ing process [in line with 2].

Risk Management Plan The risk management plan, as a part of the CRMS, emerges Proactive methods
from the risk management strategy as an annual plan. It
describes the facility’s activities and goals for the given pe- Peer Review Procedure Peer review is a continuous, systematic and critical reflec-
riod in relation to the CRMS and is coordinated with other tion of personal performance and experience by experts
management plans. involved in patient care. The open and direct exchange of
information on aspects of good patient care, among expert
Risk Matrix The risk matrix is a graphic representation in which risks are
colleagues from different fields as equals, serves to promote
classified on a scale according to impact and likelihood and/
mutual learning with the aim of achieving continuous im-
or frequency [3].
provements in patient care.
Risk Appraisal Risk appraisal covers: risk identification, risk analysis and Peer review was originally conceived as a proactive method.
risk assessment. However, it can also be used as a reactive method, in re-
sponse to a certain event (for example, in the case of a suspi-
Indicators An indicator is a quantitative measure that can be used to
cious quality indicator).
monitor and appraise important process-related, executive,
management and support functions [4]. Audits An audit is a systematic, independent and documented proc-
ess to gather (audit) evidence; following the latter‘s objective
evaluation, it serves to determine the extent to which the
audit criteria have been fulfilled [5].
Process Oriented Risk PORA provides a systemic analysis of incidents or close calls
Analysis (PORA) based on the analysis of patient care procedures. PORA is
based on the following approaches: the Failure Mode and Ef-
fect Analysis (FMEA), the Root Cause Analysis (RCA) and the
London Protocol [6].

12 13
Fault Tree Analysis (FTA) The Fault Tree Analysis (FTA) establishes a graphic connec- Proactive tools
tion between an incident that could potentially have result-
ed in harm to the patient and the corresponding sources Poka Yoke This Japanese term describes a procedure that, by means of
and causes of failure. technical precautions, is intended to identify and prevent
Failure Mode and Effect The FMEA serves to analyse and apprais risks involved in failure proactively. For example, wall-mounted connections
Analysis (FMEA) complex systems of processes and is based on a considera- for oxygen and compressed air are standardised in such a
tion of all individual subsystems or process steps (further in- way as to prevent mix-ups [11].
formation: [7]). Recommendations Recommendations are national and international guide-
Scenario Analysis A scenario analysis is a pictorial description of complex risks lines, drawn up by organisations, professional societies and
with respect to their causes, frequency of occurrence and healthcare organisations with the aim of setting standards
possible effects based on a hazard list. The risks are depicted for safe patient care. One such example is the APS’ recom-
in a risk matrix based on defined risk criteria. In the context mendations.
of risk management, the ‘credible worst-case’ scenario is ap- Directives Directives are statutory and sub-statutory, normative require-
plied [8] for this purpose. ments, a deviation from which can lead to direct sanctions.
Systematic Systematic data collection serves as a proactive method for Examples are the Protection against Infection Act and the
data collection identifying risks and deriving preventive measures. This Medical Devices Act.
could be, for example, the results of surveys, harm registers
or complication statistics.
Surveys Surveys are systematic feedback from patients, employees Reactive methods
and third parties, with the aim not only to increase satisfac-
tion of the respondents and optimise procedures, but also to DAMAGE EVENT ANALYSIS
improve patient safety.
Mortality and A Mortality and Morbidity Conference is a regularly held,
Crew Resource Management is a set of training procedures Morbidity Conference structured oral presentation and analysis of selected deaths
Crew Resource especially the non-technical abilities of an institution’s staff (M&M Conference) or serious pathogeneses, the aim of which is to improve fu-
Management to empower them to handle critical situations through the ture patient treatment and make it safer (further informa-
optimum use of all resources and information. Examples tion:[12-14]).
from field of medicine are: labour ward or trauma room
London Protocol The London Protocol is a systematic investigative technique
training (further information: [9,10]).
used to analyse serious harm. It was developed based on
the Organisational Accident Causation Model and aims to
achieve a comprehensive identification of both systemic as-
pects as well as individual causes (further information:[15]).
Error and The purpose of ERA is the systemic analysis of incidents or
Risk Analysis (ERA) close calls and is based primarily on the London Protocol
(further information:[16, 17]).

14 15
ANALYSIS OF CRITICAL EVENTS List of abbreviations used

Complaints Management Complaints management is defined as a system in which APS Aktionsbündnis Patientensicherheit
complaints, praise and criticism are understood as welcome (German Coalition for Patient Safety (GCPS))
information and analysed for risks might present to patient BfArM Bundesinstitut für Arzneimittel und Medizinprodukte
care. This aims not only increasing client satisfaction and (Federal Institute for Drugs and Medical Devices)
optimising processes, but also improving patient safety. CIRS Critical Incident Reporting System
CIRS (reporting and Critical Incident Reporting Systems are based on notification DIN Deutsches Institut für Normung (German Institute for Standardization)
learning systems) of critical events, which are systematically analysed and as- EN Europäische Norm (European Standard)
sessed. If necessary, measures to improve patient safety are ERA Error and Risk Analysis
derived. Similarly, third parties are meant to benefit and FMEA Failure Mode and Effects Analysis
learn from the anonymized notifications and the measures G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee)
resulting therefrom. ISO International Organization for Standardization
CRM Clinical Risk Management
CRMS Clinical Risk Management System
ONR ON Rule
PDCA Plan-Do-Check-Act
PEI Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines)
Reactive tools PORA Process Oriented Risk Analysis
RCA Root Cause Analysis
Additional reporting Additional reporting systems exist alongside CIRS in the
systems field of clinical risk management. These include compulsory
reporting systems such as that of the Federal Institute for
References
Drugs and Medical Devices (BfArM) or the Federal Institute
for Vaccines and Biomedicines (PEI). These reporting systems
1. DIN EN ISO 9001:2015-11: Qualitätsman- 4. Joint Commission on Accreditation of
primarily serve the purpose of risk identification.
agementsysteme - Anforderungen (ISO Healthcare Organizations (1991): Primer
Root Cause Analysis (RCA) The RCA is a set of various methods that endeavour to iden-
9001:2015), Kapitel 9.3, Beuth Verlag, on indicator development and applica-
tify the root causes of a specific event. One prominent ex-
Berlin 2015 tion. Oakbrouk Terrace: One Renais-
ample is the Ishikawa Diagram.
sance Blvd.
2. Cox S, Cox T (1991): The structure of em-
ployee attitudes to safety – a European 5. DIN EN ISO 9000:2005-12: Qualitäts-
example. Work and Stress 5(2);93-106 managementsystem – Grundlagen und
Begriffe, Kapitel 3.9.1., Beuth Verlag,
3. ONR 49000:2014: Risikomanagement Berlin 2005
für Organisationen und Systeme –
Begriffe und Grundlagen, Kapitel 2.1.14, 6. Cartes I (2012): Prozessorientierte
Austrian Standards Plus Publishing, Risikoanalyse (PORA), das Krankenhaus
Wien 2014 (6);585-590

16 17
7. U.S. Department of Veterans Affairs, 13. Gordon LA: Gordon’s Guide to the Surgi- Feedback Publication details
VA National Center for Patient Safety: cal Morbidity and Mortality Conference,
Healthcare Failure Mode and Effect APS Recommendations are tools for im- Aktionsbündnis Patientensicherheit e.V.
Hanley & Belfus Inc., Philadelphia1994
proving patient safety. These tools require Am Zirkus 2
Analysis (HFMEA). Available at: http://
continuous further development and 10117 Berlin
www.patientsafety.va.gov/professio-nals/ 14. Öfner-Velano, D: Morbiditäts- und
adaptation. The APS therefore expressly Germany
onthejob/hfmea.asap (Accessed 22Feb. Mortalitätskonferenzen in: Gausmann welcomes every form of feedback. Should Phone +49 (0)30 3642 816 0
2016) P, Henninger M, Koppenberg J: Patien- you, in perusing or using this Recommen- Fax +49 (0)30 3642 816 11
tensicherheitsmanagement, deGruyter, dation, discover inconsistencies, ambi-
Members of the working group and authors
8. ONR 49002-2:2014: Risikomanagement Berlin 2015 guities or errors, we would appreciate if
of the Recommendation:
für Organisationen und Systeme – Teil you would point these out and render
Debacher, Dr. Ulf, Asklepios
suggestions for improvement.
2: Leitfaden für die Methoden der 15. Taylor-Adams S, Vincent C: Systema- Felber, Dr. Andreas
nalyse klinischer Zwischenfälle – Das Fengler, Dr. Axel, medilox GmbH
Risikobeurteilung – Umsetzung von ISO Furthermore, you may feel free to address
Gausmann, Dr. Peter, Gesellschaft für
31000 in die Praxis London Protokoll (German Translation) questions, which have not been dealt
Risikoberatung mbH
Available at: https://www1.imperial. with in this recommendation, directly to
Gurcke, Ingo, Marsh Medical Consulting GmbH
9. Musson D, Helmreich R (2004): Team ac.uk/resources/3AD8B321-0916-47D2- the APS.
Haeske- Seeberg, Dr. Heidemarie, Sana Kliniken AG
Training and Resource Management A196-1A993E36D0B5/londonprotocol- Jahn, Brigitte, Sana Kliniken AG
in Health Care: Current Issues and deutsch.pdf (Accessed 22 Feb. 2016) Jaklin, Johannes, Marsh Medical Consulting GmbH
Note:
Future Directions. Harvard health policy Löber, Dr. Nils, Charité Berlin
Normally, the recommendation is to be
Mc Dermott, Fiona, Institute for Patient Safety,
review. 5(1);25-35 16. Zala-Mezö E, Bezzola P, Hochreutener revised after a period of three years by
University Bonn
MA (2007): Konzept der systemischen the publisher.
Rothe, Katja, DQS GmbH
10. Rall M, Lackner CK (2010): Crisis Res- Analyse von Behandlungszwischen- Spengler, Ulrike, Ev. Krankenhaus Witten gGmbH
source Management, Notfall- & Ret- Please address all of your questions, sug-
fällen in Anlehnung an das „Lon- Strametz, Prof. Dr. Reinhard, RheinMain University of
gestions and feedback to:
tungsmedizin, 13(5):349-356 don Protocol“ von Sally Adams und Applied Sciences
Aktionsbündnis Patientensicherheit e.V.
Weidringer, Prof. Dr. Johann Wilhelm, Bavarian
Charles Vincent. Stiftung für Patien- Am Zirkus 2
11. Shingo S: Zero Quality Control: Source Chamber of Physicians
tensicherheit. Available at: http:// 10117 Berlin
Inspection and the Poka-yoke System. Germany Editorial management and leadership of the
patientensicherheit.miro-net.ch/
Portland: Productivity Press, 1986 kontakt@aps-ev.de working group:
dms/de/themen/3110_ERA_konzept_ Strametz, Prof. Dr. Reinhard, Hochschule RheinMain
12. Becker A (2013): Qualitätskriterien syst_analyse_d/Konzept%20der%20 Debacher, Dr. Ulf, Asklepios
systemischen%20Analyse%20von%20 This guideline can also be downloaded Haeske- Seeberg, Dr. Heidemarie, Sana Kliniken AG
erfolgreicher Morbiditäts- und Mor-
talitätskonferenzen. Interdisciplinary Behandlungszwischenf%C3%A4llen.pdf free of charge at: www.aps-ev.de Translation of English version of this Recommen-
(Accessed 22 Feb. 2016) dation:
Contributions to Hospital Management:
DOI: 10.21960/201707/E Strametz, Prof. Dr. Reinhard, RheinMain University
Medicine, Patient Safety and Economics. of Applied Sciences
17. Herold A. Die retrospektive Fallana-
23.10.2013 #015. Available at: http:// Mc Dermott, Fiona, Sana Kliniken AG
lyse – ein Instrument zur Aufarbeitung
www.clinotel- journal.de/article-id-015. Weidringer, Prof. Dr. Johann Wilhelm, Bavarian
von Schadenfällen in der Medizin in: Chamber of Physicians
html (Accessed 22 Feb. 2016)
Gausmann P, Henninger M, Koppenberg
Graphic design and typesetting: www.pinger-eden.de
J: Patientensicherheitsmanagement,
First German version: April 2016
deGruyter, Berlin 2015
First English version: February 2017
18 19

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