Seminar on QM
in German hospitals
Quality assurance in
German hospitals
QM - Implementation
Mandatory
Certifications of
German Health Care
Providers
Oncological Centers &
OnkoZert-Certification
Scheme
QM in Teaching
QM in Clinical studies
08.11.2013 - Dr. Erwig Pinter
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
1
Quality assurance in
German hospitals
Dr. Erwig Pinter, QKB
Qualität im
Krankenhaus
Beratungsgesellschaft mbH
Topics
1.
2.
3.
4.
5.
6.
7.
8.
9.
Quality and hospitals in Germany
Internal quality assurance
Focus in different Certification Schemes
External quality assurance
Risk management
Quality management in clinical reality
Transparency and Marketing with Quality
Assessment of the benefits of QM
Literature
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
3
Topics
1. Quality and hospitals in Germany
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
4
Definitions
Terms according to DIN EN ISO 9000:2005
 Quality:
“degree to which a set of inherent characteristics fulfils
requirements”
 Quality management (QM):
“coordinated activities to direct and control an
organization with regard to quality”
 Quality management system (QM-System):
“management system to direct and control an
organization with regard to quality”
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
5
Hospitals in Germany
Definition according to § 2 no. 1 Hospital Law:
 Medical and nursing assistance
 Diagnosing, healing or relieving of diseases, suffering or
disfunctions or obstetrics
 Board and Loading of persons
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
6
Types of hospital service
Service
Type
Stationary
treatment
Admission

Treatment

Board

Loading

Pre- and poststationary
Day
Unit
Outpatient
treatment



Connected to
Stationary
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH


7
Segmentation of hospitals by ownership
Public Hospitals:
 Owner is Federal Republic or a Federal State, Communal
Authority or a Social insurance
Charity based Hospitals:
 Owners are Churches, Social associations foundations,
Associations
Private Hospitals:
 Owners are private companies, organisations or persons
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
8
Ownership segments acute hospitals
2017
acute hospitals in Germany
Source: destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
9
Ownership segments acute hospitals
2017
acute hospitals in Germany
718
charity based hospitals
0,17 Mio.
beds
6,41 Mio.
cases/year
601
public hospitals
0,24 Mio.
beds
9,1 Mio.
cases/year
698
private hospitals
0,09 Mio.
beds
3 Mio.
cases/year
Source: destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
10
Segmentation data acute hospitals
< 100
beds
100-199
beds
200-499
beds
> 500
beds
Total
number
696
443
624
254
2017
0,8 Mio.
2,2 Mio.
12,4 Mio.
8,0 Mio.
18,3 Mio.
 Length of stay
in days
8,8
8,0
7,6
7,4
7,8
 Number of
personnel
51
199
466
1666
-
Number of
hospitals
Number of
inpatient care
Source: destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
11
Owners segments prevention/reha hospitals
1212
facilities in Germany
Source: destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
12
Owners segments prevention/reha hospitals
1212
facilities in Germany
321
charity based
0,07 Mio.
beds
0,3 Mio.
cases/year
232
public
0,03 Mio.
beds
0,4 Mio.
cases/year
659
private
0,11 Mio.
beds
1,3 Mio.
cases/year
Source: destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
13
Segmentation data prevention/reha hospitals
Number of
hospitals
Number of
inpatient care
 Length of stay
in days
 Number of
personnel
< 50
beds
50-99
beds
100-199
beds
> 200
beds
Total
number
286
261
355
310
1212
0,8 Mio.
0,19 Mio.
0,6 Mio.
1,05 Mio.
2 Mio.
30,3
27,7
25,35
25
25,5
19
39
82
148
-
Source: destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
14
Key data
Number of German hospitals decreased by 8%
between 2000 und 2011
2500
hospitals
2000
1500
public
1000
charity based
500
private
0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
Source: destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
15
Key data acute hospitals
Population in Germany: 82 Mio.
2017 acute
hospitals in total
6 Mio.
emergency cases
18,3 Mio.
stationary patients
18 Mio.
outpatients
83 Mrd. € turnover cost/year
= 3,6 Bio. Rubel
(3,2 % gross national product)
160 tsd. Physicians
1,1 Mio.
professionals
700 tsd. Nurses, Function service,
Medical engineers
80 tsd. Administration
200 tsd. Others (technicians etc.)
Source: DKG 2011 and destatis, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
16
Topics
2. Internal quality assurance
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
17
Development of QM in Germany
2013:
- Mandatory certification of
rehabilitation hospitals,
- quality assurance report with
289 quality indicators,
- patients rights law
1975:
Quality Control:
Munich perinatal
study
1989:
external quality
assurance
1997-2000:
Demonstration
project QM
2000:
Internal QM,
federal governing board
for quality assurance
2004:
G-BA
2005:
Quality assurance report,
Alliance Action for patient
safety
 Increasing requirements for proving and for transparency
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
18
Organisations developing quality assurance
 National Association of Statutory
Health Insurance Funds
 National Association of Statutory
Health Insurance Physicians
 National Association of Statutory
Health Insurance Dentists
 German Hospital Federation
 Federal Medical Chamber
 Council of Nursing
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
19
Legal framework
Social Code Five (SGB V)
 § 70 SGB V: Quality, Humanity and Economic Efficiency
 Health care for the Insured according to the
recognized medical evidence
 Sufficient, advisable and not exceeding the extend
of necessity
 According to the professionally required quality
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
20
Legal framework
Social Code Five (SGB V)
 Since the year 2000 steadily more specific and demanding:
 § 135a SGB V: Requirements for quality assurance
 Implementation and further development of an
internal QM
 Participation in measures for external quality assurance
 § 137 SGB V: Regulations and decisions for QM
 Federal Joint Committee (G-BA) formulates basic
requirements for an internal QM and
 defines quality indicators for the legally requested
quality report
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
21
Common Federal Council
Federal Joint Committee (G-BA)
 Highest regulating committee of the self governing authority of
the health care partners


Regulatory competency


QM in the medical care
Defines services of health professions to be
paid by the health insurance funds
Regulations in quality
management:
internal QM, external
quality assurance
(=quality control),
quality report
G-BA
(Federal Joint Committee)
Medical
Professions
Medical
Care
Dental
Surgeon
Hospitals
Health Insurance Funds
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
22
Requirements for an internal QM in Germany
Mandatory elements of the internal QM according to the
Federal Joint Committee (G-BA)
Patient orientation
Target-orientation
and flexibility
Continuous
improvement
Efficiency
Elements of the
internal QM
Employee-orientation,
cooperation and
participation
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
Process orientation
Responsibility and
leadership
Preventing and
handling of failures
23
Internal QM
Federal Joint Committee (G-BA) requirements for the
internal QM-System in a hospital
Processes
Structure
Other requirements
QM as part of the
facility policy
Governing council or
Steering committee
Effectivity and
efficiency
Patient orientation
QM-officer for the
executive management
Cost-Benefit relation
Responsibility of the
hospital directorate
Key processes, Evidence
based Medicine with
clinical pathways,
guidelines, standards
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
24
AWMF Guidelines
Working Group of the Scientific Medical Associations
(AWMF):
 Systematically developed (Evidence based medicine)
 Describe the Current state of the art and medical science
 Ascertain the decision making procedures of doctors and
patients in respect to an adequate medical diagnostic and
treatment standard for specific diseases or health
problems
 Clear recommendations to act based on assessements of
the scientific value and usability of study results
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
25
Clinical relevance of the AWMF Guidelines
AWMF:
 Guidelines are corridors for the medical decisions and
actions
 Deviations are possible in certain cases, but reasons have
to be stated
 The workflow according to the scientific guidelines of the
AWMF has to be adapted to the individual applicability in
an individual situation according to the parameters
 indication
 consultation,
 preferences
 participation in decision making
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
26
Classifications of AWMF guidelines
AWMF:
 S1: Recommendations of scientific expert groups
 S2: Guidelines based on evidence (S2e) or consensus
of a discipline representing committee (S2k)
 S3: Guidelines based on evidence as well as on the
consensus of a discipline representing committee
Remark:
 In Germany it is important for the doctors liability to obey
in detail at least the S-3 guidelines (and a must to get
some certifications like OnkoZert)
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
27
Development process of AWMF-guidelines
5 stages in the life of a guideline (AWMF)
Planning and organisation
Development of a guideline
Editorial process and Publishing
Implementation
Evaluation and Planning the Updating
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
28
Special characteristics
Certification
Basics
General and special Certification Schemes
ISO
KTQ
JCI USA
Requirements
DIN EN ISO 9001
QuestionCatalogue with 6
categories
JCIOnkoZert Questionnaire
accreditation
with 10 chapters
standards in 14
German Cancer Soc.
chapters
Certification audit
Self assessment
and conformity
assessment
Self
assessment,
accreditationsurvey
Certification audit by
team of general QMauditor and oncological
expert
Structured QM,
process orientation,
certification of
organisational parts of
the hospital possible,
internationally
recognized,
yearly control audit,
internal audits
Certification of
the entire
hospital,
specific German
certification
model for health
sector
Certification of
the entire
hospital,
from USA,
internationally
recognised
Oncological centers:
comprehensive cancer
centers, cancer organ
center, cancer entities,
cancer based items,
certified general internal
QM-System as prerequirement
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
OnkoZert
29
ISO-Certification
1. Select a certifying organisation
2. Formal pre-check of the certification application
3. Certifying organisation defines audit team
4. Audit stage 1
5. Audit stage 2
6. Issuance of the certificate for 3 years
7. Yearly conformity audits
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
30
Certification status in acute hospitals
Problems in status assessment:

no publicly available source about precise certification numbers since
certification in acute hopitals is voluntarily




Each certified hospital promotes its own certification
Only active KTQ certifications are listed publicly
ISO certifications are not released from the certification organisations
Private data sources about hospitals differ in definitions from the
Federal Authority of Statistics
Result: We could evaluate for you the current certification situation only on
a reference basis of about ¾ of the 2017 acute hospitals, namely in 1576,
but we can offer at least an overall view of conclusions
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
31
Certification status in acute hospitals


Number of non-certified acute hospitals is still predominant
Highest portion of certified acute hospitals is in the charity based owner
sector
Owner
Charity
Public
Certified
285
217
Noncertified
345
315
Private
127
287
Hospitals
629
947
80%
Certification status in acute hospitals
69%
70%
50%
59%
55%
60%
45%
40%
41%
31%
30%
20%
10%
0%
charity based
public
private
certified
not certified
Source: DKA, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
32
Market share of Certification Schemes
Acute hospitals:

about 40 % of the acute hospitals in Germany are certified
in General Certification Schemes (status 2012)

Many hospitals are additionally
certified in specific disease
certification Schemes
Rehabilitation hospitals:

Each rehabilitation
hospital is mandatorily
required to
show its valid certificate
Market Share of Certification Schemes
in German acute hospitals
60%
52%
50%
48%
40%
30%
20%
10%
0%
KTQ
ISO
Source: DKA, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
33
Certification Schemes in owner sectors
Distribution of KTQ and ISO Certifications in owner-sectors:
 ISO certification:
more frequently at
private acute
hospital owners
60%
50%
 KTQ certification:
more frequently in
charity based and
public acute hospitals
Certification distribution
70%
61%
56%
53%
44%
47%
39%
40%
30%
20%
10%
0%
charity based
public
KTQ
private
DIN EN ISO
Source: DKA, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
34
JCI-Certifications
These three hospitals are certified in Germany
according to JCI:
 Central Military Hospital Koblenz
 Clinics of Red Cross Berlin
 Communal Central Hospital Chemnitz
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
35
Standards
ISO QM Standards:
 DIN EN ISO 9000:2005, Quality management systemsFundamentals and vocabulary
 DIN EN ISO 9001:2008, Quality management systems,
Requirements
 DIN EN 15224:2012, Health care services - Quality
management system
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
36
Critics to General Certifications Schemes
Not specific for Health Care.
Origins from Industry
3 year periods between conformity
assessements
Valuable structured approach but not
all ISO elements meet the special
needs of indiviual patient
Self-assessment is big workload (1/2
year) in the valuable overall evaluation.
Implementation of the possible
improvements however is separate act
Some doctors see much formalism not
really improving outcome but
hindering patient work
If executives are not convinced by QM
and their necessary daily support goes
to a minimum:
the hospital freezes in QM between the
3 yearly self-assessements ->
No further organization developement
Special
characteristics
Basics
KTQ
Benefit
ISO
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
37
Assessment after 20 years QM experience
Preferred is structured QM approach of ISO type but only with special
touch to meet the health sectors needs:

Development in the health-care sector in understandable language of
the health care professionals






Focus on patient orientation
Evidence based medicine
Risk-management
Prevention of defects and non-conformities
Usable for all health-care organisations
For small and very complex organisations with all necessary aspects
(patient care, medical competence, clinical pathways etc.)
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
38
The prospective Standard in Europe
DIN EN 15224:2012







Defines ISO 9001 for the health-care sector

Combined certification according to DIN EN ISO 9001 is possible
Specifically designed for all healthcare services
Requirements to the QM-system
Will become the main certification standard
Language of the health-care sector
Emphasizes the process orientation and risk-management
Three standards: clinical process, process of science and process of
teaching
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
39
Associations emphasizing and influencing QM
Examples for associations of medical doctors



German Association of hematology and oncology (DGHO)


German Association of orthopedics and traumatology (DGOU)
German diabetes Association (DDG)
Association of children hospitals and children departments in Germany
e.V. (GKindD e.V.)
German association of angiology (DGA)
Example for other associations

German Cancer Association (DKG)
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
40
Special Certification schemes of Associations
Certificate
Association
Number of certified
facilities
OnkoZert
German Cancer Association
Organ-Cancer Centers: 860
Oncological Centers:
57
Comprehensive Cancer
Centers (CCC)
3
DGHO
German Association of
Hematology and Oncology
Oncological Centers:
Competence Centers:
Study Centers:
German Association of
Diabetology
For Clinics:
Basic recognition:
248
Diabetologicum:
48
Podological specialist for
treatment of diabetic feet: 79
Quality Seal
DDG
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
40
3
6
41
Special Certification schemes of Associations
Certificate
Association
Quality seal for
children
hospitals
Association of children hospitals
and children clinics in Germany
Centers for
vessel diseases
German Asociation of
angiology, German Association
of vessel surgery, German
Association of radiology
Nephrological
focus clinic
German Association of
nephrology
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
Number of certified
facilities
Clinics for Children
and adolescent:
280
Vessel Centers:
66
Focus Clinics:
22
42
Topics
3. Focusing different Certification Schemes
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
43
DIN EN ISO 9001:2008
Main chapters of DIN EN ISO 9001:2008:
4. Quality management System
5. Management Responsibility
6. Resource Management
7. Product realization
7.5 Production and Service provision (Patient care)
8. Measurement, analysis and improvement
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
44
KTQ – catalogue version 5.0
Categories
1.
2.
3.
4.
5.
6.
Patient-orientation in Patient Care
Ensuring employees-orientation
Safety in Hospital
Information
Hospital management
Quality management
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
45
JCI – catalogue 4. revision I
Patient oriented Standards








International Targets for Patient safety
Access to and continuity of treatment
Patient and family rights
Assessment of Patients
Treatment of Patients
Anesthesiology und surgical treatment
Management and application of medicines
Training of patients and of their relatives
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
46
JCI – catalogue 4. revision II
Organisational oriented Standards






Quality improvement and Patient safety
Prevention and Control of infections
Control, Leadership and Management
Facility Management and security
Qualifications of employees and further education
Communication and Information management
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
47
OnkoZert - Survey
1. Structure and processes (e.g tumour boards)
2. Organ-specific diagnostics
3. Radiology
4. Nuclear medicine
5. Surgical Oncology
6. Chemotherapy/Internal Oncology
7. Radiooncology
8. Pathology
9. Palliative Care und Hospice service
10. Tumour documentation/Outcome quality
1.
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
48
Trauma Network - Requirements
Compliance with requirements defined in checklists:
 Profile checklist for facilities for the Basic Treatment of
severely injured persons
 Checklist for a Regional Trauma Center
 Profile Checklist for a Supraregional Trauma Center
Requirements:
 Personnel requirements
 Facility and equipment requirements
 Measures for Quality Assurance
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
49
Topics
4. External quality assurance
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
50
External quality assurance
Measures for external quality assurance according to the
Federal Joint Committee’s requirements:
Goal: improvement of the quality and comparability of health
care services
 German-specific
 Documentation and transmitting of data to the evaluating
institute in regard to defined quality indicators in 30
chapters
e.g. obstetrics, transplantation of cardiac pacemaker
 Recording and analyzing data across all hospitals in
Germany
 Some quality indicators are also part of the quality report
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
51
External quality assurance
1. Patient care and documentation
2. Transmitting the data to the AQUA Institute and regional
authority for quality assurance
3. The regional authority and the AQUA Institute analyze the data
4. Inform hospitals about results of the analysis
5. “Structured dialog” in significant deviations from normal
6. Objective agreement on quality improving measures
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
52
Results of the external quality assurance 2012




1658 hospitals participated
465 quality indicators of 30 chapters
4 Mio. data sets to analyze
Results:
 In total, the quality of health care in Germany is on a
high level
 But specific potentials for improvement identified:
E.g. Current documentation in the field of liver
transplantation has to be strengthened with more
parameters
Quelle: AQUA Institut, 2013
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
53
Quality reports of hospitals
 Legal obligation for hospitals to publish yearly a quality
report
 Content, range and data format are defined by the Federal
Joint Committee (G-BA)
 Part A: information about structure and health care
services of the hospital
 Part B: information about structure and health care
services of specialty departments of the hospital
 Information about quality assurance
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
54
Topics
5. Risk management
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
55
Risk management
 Risk
“the combination of the probability of an event and its
consequences”
 Risk-management
“coordinated activities to direct and control an
organization with regard to quality”
 Clinical risk
“negative effects on the patient outcome according to
quality requirements in health care“
 E.g. wrong treatment, complications
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
56
Risk management
Risk management as part of quality management





Avoiding to do the same work twice
Efficient resource management
Harmonised documentation
Transparency of structures
Legal security
QM
RM
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
57
Risk management process
becomes more and more
important for hospitals
in Germany
 Patients rights law
 DIN EN 15224:2012
 Alliance Action for
patient safety
1. Establishing
the context of use
2. Risk identification
3. Risk analysis
4. Risk evaluation
6. Monitoring and review
Risk management
5. Risk measures
DIN ISO 31000:2011
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
58
Risk management
Partners of the Alliance action for patient safety
 Federal Joint Committee
 German Federation of Hospitals
 Health Insurers
 Charité Berlin
 Private Hospital Chain
Projects:




Action on Patient Safety
Action Clean hands! (Hygienic project)
Hospital network CIRS Germany
Time out procedures
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
59
Risk management
Survey of the Alliance Action for patient safety
 Deals with the status of implementing a clinical risk
management system in Germany
 Results:
 484 hospitals participated
 27% implemented a risk
yes
27%
partially
31%
management system
 31% have a strategy for
implementing a system
intention
16%
no
26%
Survey of the Alliance Action, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
60
CIRS
Critical incident reporting system (CIRS)
 Goal: prevention by collecting information about
critical incidents, learning from failures
 Factors for success:
 No sanctions
 Voluntary, anonymous, trust
 Analysis of incidents by experts
 System-oriented
 Mainly based on a program from a
medical liability insurer
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
61
CIRS
Realisation of CIRS in German hospitals
 Survey of the Alliance Action for patient safety
 35% have a systematic CIRS
 Main risk factors identified yet:
 Interaction between
departments
 pharmacotherapy
 Infections
 Hygiene
systematic
CIRS
35%
nonsystematic
13%
no
18%
not yet
15%
intention
19%
Survey of the Alliance Action, 2012
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
62
Risk management
Learning from the aviation








CIRS-systems
Checklists
Certification procedures for medical and nursing personnel
Training Centers
Simulator Training
Psychological behavior in stress situations
Become sensitive to systematic non-conformities
Focus on preventive action
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
63
Patients rights law
Goal: Patient safety and empowerment of patients
 Codification of court decisions in more than the last 30
years medical liability claims
 Asserts legally the status of the continuously extended
patients rights and the defined good medical practice in
Germany by Courts
 Some new requirements:
 Doctor has to proof information consent
(now it is doctors burden to proof before
court. Before it was patients burden)
 Requirements regarding documentation:
General rule: “What is not documented
did not happen”

Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
64
Topics
6. Quality management in clinical reality
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
65
Acute hospital segmentation in treatment/size
Level of competence
Differentiation and
scope of service
spectrum
Maximal
spectrum
hospitals
Hopitals with main
focuses
Regular and basic services
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
1000 beds +
400-1000 beds
20-400 beds
66
QM implementation approaches differ
QM-approaches differ due to hospital size and service:
We experienced during the 20 years QM realisation in respect
to type and extent of QM realisation:
Dominating factors in initiatialization and realisation of QM
 Basic Services:
Individual executive experiences
 Main focus Services: Recommendations of associations
 Maximal Service:
Legal requirements factor
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
67
QM in regular and basic hospitals
Short way communications and decisions
 Two possible ways:
 QM is responsibility of some individual persons
additionally to and together with their actual work or
 Special appointed member of management with
responibility for Qualitätsmanagement and e.g. riskmanagement
 Important: Priority setting is a must in different QM-projects
QM
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
68
QM in main focus hospitals
 Central QM reports to executive management with
some special employees for QM
 Appointed QM persons (QMB=ISO 5.5.2) in individual
clinics with tasks and responsibilities more specifically
differentiated
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
QMB
QMB
QMB
Central QM
69
QM in maximal spectrum hospitals




Central QM in the top management of the Holding
Local QM in the different sites
Specialists for the different QM-sectors in the central QM
Central QM responsible for Public relations and marketing
with QM-topics and the further strategic developing of
QM as well as of their organisation (think tank).
Top management and central QM
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
QMB
QMB
QMB
Central QM
QMB
QMB
QMB
Central QM
QMB
QMB
QMB
Central QM
70
Topics
7. Transparency and Marketing with Quality
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
71
Transparency and Marketing with Quality
4QD-Quality clinics
Online portal with open comparative
ranking of participating primarily
private hospitals
Hospital navigator
Online search for the best suitable hospital on basis of
parameters important for patients provided by biggest
health insurer
Top-ranking doctors list Focus
Ranking list of hospitals or of
doctors in weekly magazin Focus
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
72
Transparency and Marketing with Quality
4QD-Quality clinics



Initiative of private hospital chains , e.g. Sana, Rhön, Asklepios

Quality indicators:
Voluntary partcipation of hospitals
Mutual audits of the participating
clinics
 340 indicators regarding
Outcome quality
 21 indikators regarding
patient safety
 10 each regarding patient
and practitioner satisfaction
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
73
Transparency and Marketing with Quality
4QD-Quality clinics

Search for the suitable hospital according to the speciality clinics,
indications, treatment possibilities and location


Online search with certain parameters or with the body picture
Patient gets informations about:






Clinic details
Quality parameters
Quality Certificate
Treatment spectrum
Main focuses
Equipment/Service
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
74
Transparency and Marketing with Quality
Hospital navigator


Initiative of the statutory health insurance (AOK)
Informations are based on the
 Legally requested Quality reports
 Voluntary informations of the hospitals
 Results of patient satisfaction surveys of the legal health insurers
(Patient Experience Questionaire)
 Anonymised routine data from the datapools of the health insurers

No verification procedure
regarding the voluntary
informations of the
hospitals and the Quality
reports
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
75
Transparency and Marketing with Quality
Hospital navigator

Comparison of at least two hospitals in:





General informations
Recommendations by patients
Main focuses of the hospital
Personnel
Quality Assurance with
routine data
 Legally required parameters of the QA
 Patient satisfaction
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
76
Transparency and Marketing with Quality
Top-ranking doctors list Focus

The weekly magazin “Focus” publishes periodically
ranking lists of specialised doctors and of hospitals
based on quality parameters

Quality Indicators:





Recommendations of doctor collegues
Recommendations of associations of patients
Selfassessements of the doctors
publications
Written and
phone interviews
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
77
Topics
8. Assessment of the benefits of QM
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
78
QM postgraduate education as success factor
Focus in personnel training in Germany very important

Mandatory further education of doctors has to be proven all five years
(via collection of certification points per event)

Additional special health personal trainings in QM, teambuilding,
teamwork and communication


Most important in practical terms (BÄK/Bundesärztekammer):
QM-qualification by the Federal Medical Association
 “Curriculum of medical quality management”
 200 hours in three parts in one year with examination
 Target groups:
Medical chief executives, senior physicians and Consultants
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
79
Areas for improvement

QM has to be implemented and is to be applied in the entire hospital
(S. Pilz et al. 2013)

Deficiences in the implementation (N. Kasper, 2011)
1. Application
 of the implemented methods
and elaborated standards is
not successful
Plan
1
2. Monitoring, measuring and act
 deficiencies in the
independent evaluation
of the results of QM
 deficiencies in act to improve
timely the non-conformities
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
Act
2
Do
Check
80
Areas for improvement
Surveys on behalf of the Federal Joint Committee about the perception
of the users about the Quality Reports

Patients and doctors underutilize the Quality Reports of the clinics in
the clinic selection
 Patients in majority don‘t even know the Quality Reports

Perception of the hospitals
 Quality Reports do merely adequate reflect the real spectrum and
quality of the services of a clinic
 Quality Reports have to be improved in the way of presentation,
detailedness, comprehensibility for lay people, freedom of too
narrow legal arrangement
M. Geraedts et al. 2010
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
81
Effectivity of QM
Study of the Society of Quality management in Health
Care: The role of QM personnel in hospitals
 Anonymous Online-Survey of QM-employees in health
care
 248 participants in Germany:
 different owners and sizes of the facilities
 77% of the participating facilites had been certified
S. Pilz et al. 2013
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
82
Effectivity of QM
Results
 dynamic, developmental QM contributes effectively by
 Structuring, establishing tranparency of and optimizing
the internal workflow
 Minimizing costs and risks
 Increasing patient safety
 Assisting the top management
S. Pilz et al. 2013
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
83
Effectivity of QM
Results
 The crucial success factor: Close cooperation between QM
and Top management
 Top management of successful facilites typically requires
and accepts the support by QM
70%
61%
60%
Significance of the
cooperation between
QM and executives
50%
36%
40%
30%
23%
20%
12%
Less
wenig
important
bedeutsam
important
bedeutsam
10%
0%
less
wenig
successful
erfolgreich
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
successful
erfolgreich
S. Pilz et al. 2013
84
Effectivity of QM
Different possible roles of QM in a hospital:
- Quality Control
- Moderator in
conflicts
- Management
system-designer
leading
- Change manager
- Internal Consultant
Position of QM

Control station
preservative
Organisational
development
Orientation of QM
Security Force
- Quality Control
- Repair
- Management
system-administrator
changing
Project reserve
- Project manager
- Project service
subordinate
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
Sommerhoff 2012
85
Mandatorily required QM
Certified QM in health sector is becoming more and more mandatorily
required by law:


QM as safety factor in economically stringent situations

Medical laboratories have to prove specified capabilities
Convincing evidence for benfits by QM in outcome and processes
based on our practical experience
Certifications required:


Rehabilitation hospitals
Dentists
Mandatorily QM implementation:

QM has to be implemented mandatorily by law
in each health service, e.g. practitioners, emergency medical service,
psychiatry etc.
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
86
Topics
9. Literature
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
87
Literature

Homepage Bundesministerium für Gesundheit:
http://www.bmg.bund.de/ministerium/english-version.html

Homepage Deutsche Krankenhausgesellschaft:
http://www.dkgev.de/dkg.php/cat/257/aid/10696



Homepage G-BA: http://www.english.g-ba.de/

Homepage Aktionsbündnis Patientensicherheit:
http://www.aktionsbuendnis-patientensicherheit.de/


Homepage GQMG: http://www.gqmg.de/
Homepage AWMF: http://www.awmf.org/
Homepage BÄK:
http://www.bundesaerztekammer.de/page.asp?his=4.3569
Homepage AQUA Institut: http://www.aqua-institut.de/
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
88