Results of WP6 Questionnaire. Parts 1-2
WP6. EU collaboration for Healthcare Quality Management Systems December 2013
2
3
INDEX
INTRODUCTION 4
RESULTS 6
Respondents
PART 1 - Structure of the health care system 7
1.1 Service Delivery structure 7
1.2 Financing structure 9
1.3 Legal structure 10
PART 2 – Activities to assure and improve quality of care 13
2.1 Activities aimed at health care organizations 13
2.2 Activities aimed at patients 22
2.2.1 Patient involvement 22
2.2.2 Patient empowerment, Patient surveys, Patient complaint mechanism 26
CONCLUSIONS 31
ANNEXES 33
ANNEX 1 – WP6 Questionnaire – Parts 1 and 2 33
ANNEX 2 – PaSQ Glossary and WP6 Conceptual Framework 43
4
INTRODUCTION
This document describes the results of the data analyses of Part 1 and Part 2 of the WP6 Questionnaire:
“Quality Management Systems in Member States and Exchange of Good Organisational Practice”.
The preliminary design of the questionnaire was developed according to WP6 framework and definitions and discussed with WP6 associated partners (AP), whose suggestions where collected and integrated through several rounds of consultation in September and October 2012.
The final version was prepared for the on-line survey thanks to WP2 technical support.
A pilot test was carried out by 4 partners (France, Ireland, Norway and Poland) at the end of October 2012 and the final adjustments for the on-line survey were performed during the first week of November 2012.
Data collection began on November 12th 2012 and finished on March 15th 2013.
The aim of this online survey was to collect information about:
The Quality Management Systems in EU Member States, according to PaSQ WP6 framework (Parts 1 and 2)
The most relevant Transferable Good Organizational Practices to be shared by EU Member States through Exchange Mechanisms in PaSQ (Part 3)
Perceived needs of EU Members for learning from Transferable Good Organizational Practices through the Exchange Mechanisms (Part 3)
Part 3 of the questionnaire is analyzed in another independent report.
This report is focused on parts 1 and 2 of the questionnaire: Quality Management Systems.
This document was produced by NIVEL in collaboration with MSSSI taking into account the comments of the WP6-AP.
5
METHODS
As previously indicated, WP6 questionnaire consisted of three parts. This document is focused on the analyses of the data collected in parts 1 and 2 of the questionnaire. The goal of part 1 questionnaire was to collect information about the structure of the health care system in relation to quality of care. More specifically, part 1 collected information about the service delivery structure, the financing structure, and the legal structure of the health care system in different EU member states.
The goal of part 2 questionnaire was to collect information about specific activities displayed to assure and improve quality of care in the different EU member states. More specifically, part 2 collected information about activities aimed at health care organizations and activities aimed at patients.
The information will be presented as descriptive information and will give insight into quality management systems in EU member states.
6
RESULTS
Respondents
All European member states and European member state candidates involved in the Joint Action PaSQ were approached with the request to fill out the questionnaire. After revision of duplicates, a total of 25 countries and 12 regions (see table) completed part 1 and part 2 of the questionnaire from WP6.
ID Country Region National or Regional perspective Abbreviation
236 Austria National AU
535 Belgium National BE
766 Bulgaria National BG
346 Croatia National HR
282 Czech Republic National CZ
640 Denmark National DK
818 Estonia National EE
632 Finland National FI
728 France National FR
481 Germany National DE
109 Greece National EL
459 Hungary National HU
659 Ireland National IE
606 Italy National IT
686 Latvia National LV
386 Malta National MT
721 Netherlands National NL
407 Norway National NO
375 Poland National PL
558 Romania National RO
568 Slovakia National SK
436 Slovenia National SI
275 Spain National ES
729 Spain Cantabria Regional ES1
609 Spain Extremadura Regional ES2
546 Spain Castilla y león Regional ES3
710 Spain País Vasco Regional ES4
441 Spain Galicia Regional ES5
805 Spain Madrid Regional ES6
563 Spain Comunidad Valenciana Regional ES7
343 Spain Catalonia Regional ES8
603 Spain Andalusia Regional ES9
623 Spain Asturias Regional ES10
120 Sweden National SE
254 United Kingdom Wales Regional UK1
257 United Kingdom Wales Regional UK2
276 United Kingdom England National UK
7
PART 1 - Structure of the health care system
1.1 Service delivery structure
The service delivery structure (Table 1) of most of the countries and regions is in place. Almost all countries and regions have policies that describe the required competencies for professionals (94,6%) and a competent authority that is responsible for quality management (89,2).
Table 1.Service delivery structure across countries
Frequencies Yes No Under development
Total N
Does your country / region have…
A competent authority responsible for quality management
89,2% 5,4% 5,4% 100% 37
Quality standards developed 78,4% 10,8% 10,8% 100% 37
Published national/regional performance reports
62,2% 24,3% 13,5% 100% 37
A malpractice insurance system 78,4% 16,2% 5,4% 100% 37
Policies that describe the required competencies for professionals
94,6% 5,4% 0,0% 100% 37
The countries and regions reported that the responsibilities and functions of this authority are diverse, but mainly center around collecting and analyzing information, developing standards, and identification and dissemination of best practices concerning quality management and quality outcomes. Overall, the countries and regions reported the following responsibilities and functions of their quality management authority (multiple answers were allowed):
Collecting information about quality management (90,9%)
Collecting and analyzing information about quality outcomes (84,8%)
Development of quality standards (81,8%)
Identification and dissemination of best practices (81,8%)
Education and training of healthcare workers (72,2%)
Development of guidelines on patient safety (27,3%)
Development of quality management systems (18,2%)
Development of clinical guidelines/ pathways (18,2%)
Research on quality management (0%).
In 78,4% of the countries and regions quality standards have been developed and these are mostly developed at national level (41,4%). In 31,0% of the countries and regions they are developed at regional level, in 24,1% at both national and regional level. In 3,4% of the countries and regions, development of quality standards was voluntary. Also 78,4% of the countries and regions have a malpractice insurance system, in 65,5% of the countries and regions a malpractice insurance is mandatory for health care organizations to get a license. The publication of national and/or regional performance reports is least often in place as part of the service delivery structure in European member states (candidates). Still, almost two thirds of the respondents do openly publish the performance of their health care organizations and/or health care sector (62,2%).
8
Table 2 shows the same results per country, seventeen of the 37 countries and regions have all the aspects of the service delivery structure in place (BE, BG, DK, ES, ES10, ES4, ES5, ES8, ES9, FR, IE, IT, NL, PL, RO, SE, SK). Only one country (EL) has none of the aspects of the service delivery structure in place, and two countries have only one aspect in place but some under development (EE, LV).
Table 2. Service delivery structure per country/region
Country
Competent authority responsible for quality management
Quality standards developed
Publish national/ regional performance reports
Malpractice insurance system
Policies that describe the required competencies for professionals
AU yes yes under development
yes yes
BE yes yes yes yes yes
BG yes yes yes yes yes
CZ yes yes no no yes
DE yes yes yes no yes
DK yes yes yes yes yes
EE no no yes under development
yes
EL no no no no no
ES yes yes yes yes yes
ES1 yes no no yes no
ES10 yes yes yes yes yes
ES2 yes yes no yes yes
ES3 yes yes no yes yes
ES4 yes yes yes yes yes
ES5 yes yes yes yes yes
ES6 yes yes under development
yes yes
ES7 yes yes no yes yes
ES8 yes yes yes yes yes
ES9 yes yes yes yes yes
FI yes under development
under development
yes yes
FR yes yes yes yes yes
HR yes yes under development
no yes
HU yes yes no yes yes
IE yes yes yes yes yes
IT yes yes yes yes yes
LV under development under development
no under development
yes
MT under development yes no yes yes
NL yes yes yes yes yes
NO yes under development
yes yes yes
PL yes yes yes yes yes
RO yes yes yes yes yes
SE yes yes yes yes yes
SI yes no under development
yes yes
SK yes yes yes yes yes
9
Country
Competent authority responsible for quality management
Quality standards developed
Publish national/ regional performance reports
Malpractice insurance system
Policies that describe the required competencies for professionals
UK yes under development
yes yes yes
UK1 yes yes yes no yes
UK2 yes yes yes no yes
1.2 Financing structure
Table 3 and Table 4 show that twenty countries and regions (54,1% of all countries and regions, AU, BE, DK, ES10, ES2, ES3, ES4, ES5, ES6, ES7, ES8, ES9, FR, HU, LV, NL, RO, SE, SI, UK) have financial incentives for healthcare organizations related to quality and safety. In 12 countries and regions (32,4%, CZ, DE, EE, EL, ES, ES1, IT, MT, NO, PL, UK1, UK2) there are no incentives and in 5 countries (13,5%, BG, FI, HR, IE, SK) incentives are under development.
According to the countries and regions, the financial incentives apply to the following health services (multiple answers were allowed):
Primary care (16),
In-patient care (15),
Out-patient care (14),
Other (6).
Table 3. Financing structure, overall
Frequencies Yes No Under development Total N
Does your country / region have…
Financial incentives related to quality and safety
54,1% 32,4% 13,5% 100% 37
Table 4. Financing structure per country/region
Country Financial incentives related to quality and safety
AU yes
BE yes
BG under development
CZ no
DE no
DK yes
EE no
EL no
ES no
ES1 no
ES10 yes
ES2 yes
10
Country Financial incentives related to quality and safety
ES3 yes
ES4 yes
ES5 yes
ES6 yes
ES7 yes
ES8 yes
ES9 yes
FI under development
FR yes
HR under development
HU yes
IE under development
IT no
LV yes
MT no
NL yes
NO no
PL no
RO yes
SE yes
SI yes
SK under development
UK yes
UK1 no
UK2 no
1.3 Legal structure
Table 5 and Table 6 show the extent to which countries and regions have the aspects of the legal structure in place. 94,6% of the countries and regions have legislation and/or regulation on the required training of professionals. 86,5% of all countries and regions have legislation and/or regulation to assure professional self-regulation. 94,6% of the countries have legislation to signal and deal with professional misconduct. 89,2 % of all the countries and regions have legislation and/or regulation on patient rights.
Table 5. Legal structure across countries
Frequencies Yes No Under development
Total N
Does your country / region have…
Legislation/regulation on the required training of professionals
94,6% 5,4% 0,0% 100% 37
Legislation/regulation to assure
86,5% 13,5% 0,0% 100% 37
11
Frequencies Yes No Under development
Total N
professional self-regulation
Legislation/regulation to signal and deal with professional misconduct
94,6% 5.4% 0,0% 100% 37
Legislation/regulation on patient rights
89,2% 5,4% 5,4% 100% 37
The legislation on patient rights concerns the obligation to provide information on (multiple answers were allowed):
Health information (33)
Privacy (33)
Informed consent (32)
Shared decision making (28)
Only two countries have aspects of the legal structure under development, these countries are developing legislation and/or regulation on patient rights. Twenty-eight countries and regions have all the aspects of the legal structure in place (AU, BE, DE, DK, EE, EL, ES, ES2, ES3, ES4, ES6, ES7, ES8, ES9, FI, FR, HU, IE, IT, LV, NL, NO, PL, RO, SE, SI, SK, UK). The countries and regions with the least developed legal structure are CZ, ES1 and HR, in these countries/ regions at least two of the four aspects of the legal structure are not arranged.
Table 6. Legal structure per country/region
Country
Legislation/regulation on the required training of professionals
Legislation/regulation to assure professional self-regulation
Legislation/regulation to signal and deal with professional misconduct
Legislation/regulation on patient rights
AU yes yes yes Yes
BE yes yes yes Yes
BG yes yes yes under development
CZ no no no Yes
DE yes yes yes Yes
DK yes yes yes Yes
EE yes yes yes Yes
EL yes yes yes Yes
ES yes yes yes Yes
ES1 no no yes Yes
ES10 yes no yes Yes
ES2 yes yes yes Yes
ES3 yes yes yes Yes
ES4 yes yes yes Yes
ES5 yes no yes Yes
ES6 yes yes yes Yes
ES7 yes yes yes Yes
ES8 yes yes yes Yes
ES9 yes yes yes Yes
FI yes yes yes Yes
FR yes yes yes Yes
12
Country
Legislation/regulation on the required training of professionals
Legislation/regulation to assure professional self-regulation
Legislation/regulation to signal and deal with professional misconduct
Legislation/regulation on patient rights
HR yes no no Yes
HU yes yes yes Yes
IE yes yes yes Yes
IT yes yes yes Yes
LV yes yes yes Yes
MT yes yes yes under development
NL yes yes yes Yes
NO yes yes yes Yes
PL yes yes yes Yes
RO yes yes yes Yes
SE yes yes yes Yes
SI yes yes yes Yes
SK yes yes yes Yes
UK yes yes yes Yes
UK1 yes yes yes No
UK2 yes yes yes No
13
PART 2 - Activities to assure and improve quality of care
2.1 Activities aimed at health care organizations
Table 7 shows that most countries/ regions deploy activities to assure and improve quality of care that are aimed at health care organizations. Almost every country and region has professional licensing (97,3%) and professional learning programs (91,9%). Legislation on and regulation of re-validation of professionals, as part of the professional licensing (55,6%), peer review (32,4%), and an authority or body for the accreditation of integrated health care delivery systems (10,8%) are least often present.
Table 7. Activities aimed at health care organizations, across countries
Frequencies Yes No Under development
Total N
Does your country/ region have / use:
Accreditation 70,3% 21,6% 8,1% 100% 37
Authority or body for the accreditation of integrated health care delivery systems
10,8% 75,7% 13,5% 100% 37
Center licensing 78,4% 18,9% 2,7% 100% 37
Clinical risk management
75,7% 5,4% 18,9% 100% 37
Quality improvement project/program
86,5% 0,0% 13,5% 100% 37
Professional licensing
97,3% 2,7% 0,0% 100% 37
- Register of licensed professionals
86,1% 5,6% 8,3% 100% 36
- Legislation on and regulation of re-validation of professionals
55,6% 27,8% 16,7% 100% 36
Peer review 32,4% 51,4% 16,2% 100% 37
Professional learning program
91,9% 2,7% 5,4% 100% 37
- Modules on quality and safety included in education programs
79,4% 8,8% 11,8% 100% 34
14
Table 8 shows that only one country (UK) and one region (ES4) have indicated that they have/ make use of all activities aimed at health care organizations that were asked in the questionnaire. Countries that have / make use of the least activities are BG, EE, EL, ES10, LV, MT, NO, PL, SK, these countries/ regions indicated that they have organized six or less of the presented activities. These countries differ among each other in the type of and the extent to which the activities are absent or under development.
Table 8. Activities aimed at health care organizations per country/region.
Accreditation Authority or body for the accreditation of integrated health care delivery systems
Center licensing
Clinical risk management
Quality improvement project/ program
Professional licensing
Register of licensed professionals
Modules on quality and safety included in education programs
Legislation on and regulation of re-validation of professionals
Peer review
Professio-nal learning program
AU no no yes Yes yes yes yes yes no yes yes
BE yes no yes Yes yes yes yes develop. yes yes yes
BG yes develop. yes develop. develop. yes yes develop. develop. develop. yes
CZ yes no no Yes yes yes yes yes yes no yes
DE no no yes Yes yes yes no yes no yes yes
DK yes no no Yes yes yes yes yes no no yes
EE no no yes Yes develop. yes yes no no no yes
EL no no yes Yes yes yes yes no no develop.
ES yes no yes Yes yes yes develop. yes yes no yes
ES1
yes no yes Yes yes yes develop. no develop. no yes
ES10
yes no yes develop. yes yes no yes no no yes
ES2
yes no yes Yes yes yes yes no yes no yes
ES3
yes no yes Yes yes yes yes yes no no yes
ES4
yes yes yes Yes yes yes yes yes yes yes yes
ES5
yes no yes Yes yes yes develop. yes develop. no yes
ES6
no no yes Yes yes yes yes yes no no yes
ES7
yes no yes Yes yes yes yes yes yes no yes
ES8
yes no yes Yes yes yes yes yes yes no yes
ES9
yes develop. yes No yes no yes yes yes
FI yes yes no Yes yes yes yes yes yes develop. yes
FR yes develop. yes Yes yes yes yes yes no yes yes
15
Accreditation Authority or body for the accreditation of integrated health care delivery systems
Center licensing
Clinical risk management
Quality improvement project/ program
Professional licensing
Register of licensed professionals
Modules on quality and safety included in education programs
Legislation on and regulation of re-validation of professionals
Peer review
Professio-nal learning program
HR develop. yes yes Yes yes yes yes develop. yes no yes
HU develop. develop. yes No yes yes yes yes yes yes yes
IE yes develop. develop. Yes yes yes yes yes develop. develop. yes
IT yes no yes Yes yes yes yes yes yes no yes
LV no no no develop. develop. yes yes develop. yes no yes
MT develop. no yes develop. develop. yes yes yes develop. develop. yes
NL yes no yes Yes yes yes yes yes yes yes yes
NO yes no no develop. yes yes yes yes no no yes
PL yes no no develop. yes yes yes develop. yes no
RO yes no yes develop. yes yes yes yes yes no yes
SE no no no Yes yes yes yes yes yes yes yes
SI yes no yes Yes yes yes yes yes yes yes yes
SK no no yes Yes develop. yes yes yes no develop.
UK yes yes yes Yes yes yes yes yes yes yes yes
UK1
yes no yes Yes yes yes yes yes yes develop. yes
UK2
yes no yes Yes yes yes yes yes yes develop. yes
16
Table 9 and Table 10 show that the level on which the activities aimed at healthcare organizations are organized depend on the activity. Overall these activities tend to be organized at both levels (national and regional). For the activities that were organized at only one level, slightly more activities were organized at national level (although differences were small) except for the activities Clinical risk management, Inspections, and Professional learning programs.
Table 9. The level on which activities aimed at health care organizations are organized, across countries.
Frequencies National Regional Both Other None Total N
If you have … in place, on what level is it organized / developed?
Accreditation 38,5% 19,2% 38,5% 3,8% n.a. 100% 26
Authority or body for the accreditation of integrated health care delivery systems
25,0% 25,0% 50,0% 0,0% n.a. 100% 4
External audit 29,7,0% 18,9% 27,0% 24,4% n.a. 100% 37
Center licensing
34,5% 37,9% 27,6% 0,0% n.a. 100% 29
Clinical guidelines-pathways
33,3% 8,3% 50,0% 8,4% n.a. 100% 36
Clinical risk management
11,1% 25,9% 51,9% 11,1% n.a. 100% 27
Inspections 29,7% 37,8% 24,3% 0,0% 8,1% 100% 37
Quality indicators
32,4% 16,2% 43,2% 5,4% 2,7% 100% 37
Quality improvement programs
28,1% 25,0% 46,9% 0,0% n.a. 100% 32
Professional licensing
75,0% 11,1% 13,9% 0,0% n.a. 100% 36
Peer review 41,7% 16,7% 25,0% 16,6% n.a. 100% 12
Professional learning program
11,1% 40,7% 44,4% 3,7% n.a. 100% 37
Self/evaluation system
27,0% 21,6% 21,6% 13,0% 13,5% 100% 37
* some of the questions in this table were only answered when the previous question was answered with ‘yes’ therefore the N is not 37 in all cases.
17
Table 10. The level on which activities aimed at health care organizations are organized per country/region. A
cc
red
ita
tio
n
Au
tho
rity
or
bo
dy
fo
r th
e
ac
cre
dit
ati
o
n o
f
inte
gra
ted
he
alt
h c
are
de
liv
ery
sy
ste
ms
Ex
tern
al
au
dit
s
Cen
ter
lic
en
sin
g
Cli
nic
al
gu
ide
lin
es
-
pa
thw
ay
s
Cli
nic
al
ris
k
ma
na
ge
me
nt
Ins
pe
cti
on
s
Qu
ali
ty
ind
ica
tors
Qu
ali
ty
imp
rov
em
en
t p
rog
ram
s
Pro
fes
sio
na
l
lic
en
sin
g
Pe
er
rev
iew
Pro
fes
sio
na
l
lea
rnin
g
pro
gra
m
Se
lf/e
valu
ati
on
sy
ste
m
AU national regional both both both both both national national both national
BE both other national national national regional both both national national both
BG national national both national national national national both
CZ both Both none regional both national regional national
DE other regional both national national both both regional other both none
DK national national both regional national both both national regional national
EE national national national other national national national none
EL other national other other none none national national other
ES both both regional both both regional both both both both both
ES1 both both both both both both both both regional both
ES10
regional
regional regional regional regional regional regional national regional regional
ES2 both both both both both regional both both national regional
ES3 national other regional both both regional both both regional both regional
ES4 regional
regional regional regional both regional regional both regional national both both both
ES5 both regional both both regional regional both both national both both
ES6 regional regional both both regional regional regional national regional regional
ES7 regional
regional regional other regional regional regional regional regional regional regional
ES8 regional
regional regional regional regional regional both regional both both both
ES9 regional
regional both regional regional regional regional regional regional regional
FI both both other national both none both national both both both
FR national national both both both both both both both both national national
HR national national both national both both national both both national
HU other national national national national national national other national none
IE national both both both national national both national both national
IT both other regional national both regional national both national both none
LV national national national national national national
MT other national other national other national national other
NL national national national both national national national national national national regional national
NO other other national both national national national other other
PL national both national both other national national both none
RO national national national national both both national national both national
18
Acc
red
ita
tio
n
Au
tho
rity
or
bo
dy
fo
r th
e
ac
cre
dit
ati
o
n o
f
inte
gra
ted
he
alt
h c
are
de
liv
ery
sy
ste
ms
Ex
tern
al
au
dit
s
Cen
ter
lic
en
sin
g
Cli
nic
al
gu
ide
lin
es
-
pa
thw
ay
s
Cli
nic
al
ris
k
ma
na
ge
me
nt
Ins
pe
cti
on
s
Qu
ali
ty
ind
ica
tors
Qu
ali
ty
imp
rov
em
en
t p
rog
ram
s
Pro
fes
sio
na
l
lic
en
sin
g
Pe
er
rev
iew
Pro
fes
sio
na
l
lea
rnin
g
pro
gra
m
Se
lf/e
valu
ati
on
sy
ste
m
SE national both regional national national both national regional regional national
SI national national national both both national national national national national regional other
SK both national national other both national national other
UK both both both both both both both both national national national both other
UK1 both both national both both regional both regional national regional regional
UK2 national both national both regional regional regional regional national regional regional
* the answer option ‘none’ was not given for every question, if this was the case the cells in the table above are left empty.
Table 11 and Table 12 show that the activities Accreditation, Quality indicators, Professional licensing, and Peer review are obliged in the majority of the participating countries and regions. An authority or body for the accreditation of integrated health care delivery systems and External audits are more often organized as the result of a private initiative. Internal audits, Clinical guidelines/pathways, Clinical risk management, Quality improvement programs, and Professional learning programs are recommended in most of the participating countries and regions. FR has the most obliged activities, UK1 and UK2 have the most recommended activities.
Table 11. The extent to which activities aimed at health care organizations is obliged, across countries
Frequencies Obliged Private initiative/HCO’s own initiative
Recommended Not obliged/not used Total N
Accreditation 46,2% 23,1% 30,8% n.a. 100% 26
Authority or body for the accreditation of integrated health care delivery systems
8,1% 64,9% 27,0% n.a. 100% 37
Internal audits 24,3% 29,7% 45,9% n.a. 100% 37
External audit 35,1% 45,9% 18,9% n.a. 100% 37
Clinical guidelines-pathways 24,3% 8,1% 67,6% n.a. 100% 37
Clinical risk management 41,4% 13,8% 44,8% n.a. 100% 29
Quality indicators 48,6% 5,4% 43,2% 2,7% 100% 37
Quality improvement programs 37,5% 0,0% 62,5% n.a. 100% 32
19
Frequencies Obliged Private initiative/HCO’s own initiative
Recommended Not obliged/not used Total N
Professional licensing 97,2% 0,0% 2,8% n.a. 100% 36
Peer review 50,0% 41,7% 8,3% n.a. 100% 12
Professional learning program 25,9% 14,8% 59,3,0% n.a. 100% 27
Self/evaluation system 37,8% 5,4% 37,8% 18,9% 100% 37
With respect to quality indicators, 4 countries (FI, SI, SK, UK) indicated that the results on quality indicators are publically available at hospital/facility level, 11 (AU, CZ, ES, ES1, ES10, ES3, ES4, ES5, ES9, UK1, UK2) indicated that the results are available at an aggregated level, 12 (BE, BG, DE, DK, EE, ES2, ES6, ES8, FR, IE, NL, NO) indicated availability on both facility and aggregated level. Ten countries and regions (EL, ES7, HR, HU, IT, LV, MT, PL, RO, SE) indicated that the results on quality indicators are not available at either level.
Table 12. The extent to which activities aimed at health care organizations is obliged per country/region.
Acc
red
ita
tio
n
Au
tho
rity
or
bo
dy
fo
r th
e
ac
cre
dit
ati
on
of
inte
gra
ted
he
alt
h
ca
re d
eliv
ery
sy
ste
ms
Inte
rna
l a
ud
its
Ex
tern
al
au
dit
Cli
nic
al
gu
ide
lin
es
-
pa
thw
ay
s
Cli
nic
al
ris
k
ma
na
ge
me
nt
Qu
ali
ty
ind
ica
tors
Qu
ali
ty
imp
rov
em
en
t
pro
gra
ms
Pro
fes
sio
na
l
lic
en
sin
g
Pe
er
rev
iew
Pro
fes
sio
na
l
lea
rnin
g p
rog
ram
Se
lf/e
valu
ati
on
sy
ste
m
AU private private obliged recomm. obliged obliged obliged obliged obliged Obliged obliged
BE private private recomm.
recomm. obliged recomm. recomm. obliged obliged obliged recomm.
BG obliged recomm. recomm.
obliged obliged obliged obliged recomm.
CZ private obliged obliged private recomm. private recomm. obliged obliged recomm. obliged
DE private private private recomm. obliged obliged obliged obliged private Private not obliged
DK obliged private recomm.
obliged obliged obliged obliged obliged obliged Private obliged
EE private obliged obliged recomm. obliged private obliged not obliged
EL private private private private private none recomm. obliged not obliged
ES obliged private recomm.
private obliged recomm. obliged obliged obliged recomm. recomm.
ES1 recomm. private recomm.
private recomm. recomm. recomm. recomm. obliged recomm.
ES10 private private recomm.
recomm. recomm. recomm. recomm. obliged recomm. recomm.
ES2 obliged private obliged obliged private private recomm. recomm. obliged obliged
ES3 private private private private recomm. recomm. recomm. recomm. obliged private recomm.
ES4 obliged obliged recomm.
private recomm. recomm. recomm. recomm. obliged private recomm. recomm.
ES5 obliged private recomm.
obliged obliged recomm. obliged obliged obliged recomm. private
20
Acc
red
ita
tio
n
Au
tho
rity
or
bo
dy
fo
r th
e
ac
cre
dit
ati
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ES6 private obliged obliged recomm. obliged obliged obliged obliged recomm. obliged
ES7 obliged private private private private recomm. recomm. recomm. obliged recomm. not obliged
ES8 obliged private recomm.
obliged obliged obliged obliged recomm. obliged obliged obliged
ES9 recomm. recomm. private private recomm. obliged obliged recomm. obliged recomm.
FI recomm. recomm private private recomm. recomm. recomm. recomm. obliged recomm. recomm.
FR obliged recomm obliged obliged recomm. obliged obliged obliged obliged obliged obliged recomm.
HR private obliged private recomm. obliged obliged recomm. obliged obliged
HU recomm. private private obliged obliged recomm. obliged private recomm. private
IE recomm. recomm. recomm.
private recomm. recomm. recomm. recomm. obliged recomm. recomm.
IT obliged private recomm.
private recomm. obliged recomm. recomm. obliged obliged not obliged
LV private private private recomm. obliged obliged obliged obliged
MT recomm. recomm.
recomm. recomm. recomm. obliged recomm. not obliged
NL recomm. private recomm.
recomm. recomm. recomm. recomm. recomm. obliged private recomm. obliged
NO private private private private recomm. obliged recomm. obliged recomm. obliged
PL private private private private recomm. private recomm. obliged obliged not obliged
RO obliged private recomm.
obliged recomm. obliged obliged obliged obliged obliged
SE obliged obliged obliged recomm. obliged obliged recomm. obliged private private obliged
SI recomm. private obliged obliged recomm. recomm. obliged recomm. obliged obliged recomm. obliged
SK private recomm.
recomm. recomm. private obliged obliged obliged
UK obliged recomm. obliged obliged recomm. obliged recomm. obliged obliged obliged obliged recomm.
UK1 recomm. recomm. recomm.
recomm. obliged recomm. recomm. recomm. obliged recomm. recomm.
UK2 recomm. recomm. recomm.
recomm. obliged recomm. recomm. recomm. obliged recomm. recomm.
* Empty cells means that activity is not yet in place.
21
Countries and regions that indicated that education and training of health care workers on quality and/or safety has been promoted in the past two years also specified to whom these activities have been addressed: (multiple answers were allowed)
Doctors (34)
Nurses (33)
Pharmacists (30)
Other (16)
Obstacles to a full implementation of the education and training of healthcare professionals on quality and safety are: (multiple answers were allowed)
Not enough resources available (16)
No consensus on its contents (15)
Cultural barriers (12)
Required expertise is not available (9)
Required infrastructure is not available (2)
Required technology is not available (1)
Other: No academic interest, not enough interest in quality and safety by healthcare professionals, no consensus on its purpose, the scope should be developed/ further development is needed, quality improvement is required but patient safety not mandatory and education belongs to the Ministry of education, there is no power for successful co-operation.
22
2.2 Activities aimed at patients
2.2.1 Patient involvement
Figure 1 shows that in 68% of all countries and regions patients' or citizens/consumers' organizations are involved in development of quality/safety policies and programs (AU, BG, CZ, DE, DK, ES, ES4, ES5, ES6, ES8, ES9, FR, HR, HU, IE, IT, LV, NL, NO, SE, SI, SK, UK, UK1, UK2). In 21% of the countries and regions this is not the case (EE, EL, ES1, ES10, ES2, ES3, MT, PL), and in 11% of the countries/regions this is under development (BE, ES7, FI, RO).
Figure 1. Patients' or citizens/consumers' organizations are involved in development of quality/safety policies and programs.
Figure 2 shows that in 60% of the countries and regions that indicated ‘yes’ to the question above, both patient organizations and consumer organizations are involved in the development of quality and safety policies and programs (BG, DK, ES, ES4, ES5, ES8, ES9, HR, IE, IT, LV, NL, SE, UK1, UK2). In 40% of these countries and regions only patient organizations are involved (AU, CZ, DE, ES6, FR, HU, NO, SI, SK, UK).
Figure 2. Which organizations are involved in development of quality/safety policies and programs.
Yes 68%
No 21%
Under development
11%
Patients' or citizens/consumers' organizations are involved in development of quality/safety policies and programs.
Patient organizations
40%
Both patient and consumer organizations
60%
Which organizations are involved in development of quality/safety policies and programs.
23
Figure 3 shows that in the countries and regions where patients' and/or citizens/consumers' organizations are involved, this involvement is mostly organized on both national and regional level (40%, BG, DK, ES, ES4, ES5, ES8, FR, HR, IE, IT), or national level (32%, AU, DE, DK, LV, NL, NO, SE, SK). In 16% of the countries and regions this is only organized at regional level (ES6, ES9, UK1, UK2) and 12% (HU, SI, UK) of the countries indicated that this was organized on a different level such as:
1) By law NHS bodies are obliged to make arrangements for the involvement of patients and public (and their representatives) in the planning of services, development of proposals for change and operation of services.
2) Special invitation.
3) Hospital has a council of patients with an advisory role to the hospital management.
Figure 3. On what level are these organizations involved.
Figure 4 shows the status of patients' and/or citizens/consumers' organizations as partners in the development of policies and programs. In most countries and regions (64%, DK, ES4, ES6, ES8, ES9, FR, HR, HU, IT, LV, NL, NO, SE, SI, UK1, UK2) these organizations have the status of an advising body. In 20% (BG, CZ, ES, IE, UK) of the counties and regions the organizations are seen as a formal partner. 16% of the countries and regions indicated ‘other’ which could be that the organization are seen as both a formal partner and an advising body or that they were voluntary/ voluntarily involved.
Figure 4. What status do these organizations have as partners in the development of policies and programs.
National 32%
Regional 16%
Both 40%
Other 12%
On what level are these organizations involved
Formal partner
20%
Advising body 64%
Other 16%
What status do these organizations have as partners in the development of policies and programs.
24
Table 13 gives a summary of the questions concerning patient involvement per country.
Table 13. Patient involvement activities per country/region.
Patients' or citizens/consumers' organizations are involved in development of quality/safety policies and programs.
Which organizations are involved in development of quality/safety policies and programs: - Patient organizations - Both patient & consumer organizations
On what level are these organizations involved: - National - Regional - Both - Other
What status do these organizations have as partners in the development of policies and programs: - Formal partner - Advising body - Other
AU yes P national other
BE under development
BG yes P+C both formal
CZ yes P national formal
DE yes P national other
DK yes P+C both advising
EE no
EL no
ES yes P+C both formal
ES1 no
ES10 no
ES2 no
ES3 no
ES4 yes P+C both advising
ES5 yes P+C both other
ES6 yes P regional advising
ES7 under development
ES8 yes P+C both advising
ES9 yes P+C regional advising
FI under development
FR yes P both advising
HR yes P+C both advising
HU yes P other advising
IE yes P+C both formal
IT yes P+C both advising
LV yes P+C national advising
MT no
NL yes P+C national advising
NO yes P national advising
25
Patients' or citizens/consumers' organizations are involved in development of quality/safety policies and programs.
Which organizations are involved in development of quality/safety policies and programs: - Patient organizations - Both patient & consumer organizations
On what level are these organizations involved: - National - Regional - Both - Other
What status do these organizations have as partners in the development of policies and programs: - Formal partner - Advising body - Other
PL no
RO under development
SE yes P+C national advising
SI yes P other advising
SK yes P national other
UK yes P other formal
UK1 yes P+C regional advising
UK2 yes P+C regional advising
*some of the cells are left empty because the question was proceeded by a conditional question.
When individual patients/citizens and/or patient or citizens/consumers’ organizations are involved, this concerned the discussion of results of surveys and complaint handling, but also participation in improvement projects and quality committees. Overall, countries and regions indicated that involvement took place in the following activities (multiple answers were allowed):
Development of quality criteria/standards (17)
Design of protocols/standards (14)
Evaluation of quality improvement projects (13)
Participation in (quality) committees (18)
Participation in improvement projects (21)
Discussion of results of patient surveys, handling of complaints etc. (23)
Individual patients or patient organizations are not involved (7)
26
Countries and regions indicated that patient/client rights are obliged by law, decree or contract in 86,5 % of the countries and regions (AU, BE, CZ, DE, DK, EE, EL, ES, ES1, ES10, ES2, ES3, ES4, ES5, ES7, ES8, ES9, FI, FR, HR, HU, IE, IT, LV, NL, NO, PL, RO, SE, SI, UK) and recommended by authoritative bodies in 13,5% (BG, MT, SK, UK1, UK2).
Concerning patient/client feedback complaint mechanisms are available in (multiple answers were allowed):
Complaint mechanism (35)
Broad feedback system (14)
Other (10)
The extent to which participation of patients/clients in health care organizations has been addressed concerning trusted representatives is obliged in 78,4% (AU, BE, CZ, DK, EE, ES1, ES10, ES2, ES3, ES4, ES5, ES6, ES7, ES8, ES9, FI, FR, HR, HU, LV, NL, NO, PL, RO, SE, SI, UK, UK1, UK2), recommended in 13,5 % (BG, DE, ES, IE, SK), a private initiative in 2,7% (IT), and not addressed in 5,4% (EL, MT) of all countries and regions.
2.2.2 Patient empowerment, Patient surveys, Patient complaint mechanism
Figure 5 shows that, in more than half of the countries and regions, shared decision making is obliged (55%, CZ, ES1, ES10, ES2, ES3, ES4, ES5, ES6, ES7, ES8, ES9, FI, FR, HU, IT, LV, NO, SE, SI, UK). In 28% of the countries and regions shared decision making is recommended (BE, DE, DK, ES, HR, IE, NL, RO, UK1, UK2), and in 11% it is a private initiative (AU, EL, MT, SK). In two countries, shared decision making is not used at all (6%, EE, PL).
Figure 5. The extent to which shared decision making is stimulated.
Figure 6 shows the extent to which the provision of information about patients’ legal right is stimulated. In more than three-quarters of the countries and regions this is obliged (76%, AU, BE, CZ, DE, DK, EE, ES1, ES10, ES2, ES3, ES4, ES5, ES6, ES8, ES9, FI, FR, HR, HU, IT,
Obliged 55%
Private 11%
Recommended 28%
Not used 6%
The extent to which shared decision making is stimulated.
27
LV, NL, NO, PL, RO, SE, SI, UK), in 19% it is recommended by authorative bodies (BG, ES, ES7, IE, SK, UK1, UK2), and in 5% not used (EL, MT).
Figure 6. The extent to which the provision of information about patients' legal rights is stimulated.
Table 7 shows that the stimulation of use of patient surveys to systematically monitor patient experiences is recommended in over half of the countries and regions (54%, AU, EL, ES, ES1, ES10, ES2, ES3, ES4, ES7, FI, FR, HR, IE, MT, ML, SE, SI, UK, UK, UK2). It is obliged in 30% of the countries and regions (CZ, DK, EE, ES5, ES6, ES8, ES9, IT, NO, RO, SK), and a private initiative in 16% of the countries and regions (BE, BG, DE, HU, LV, PL).
Figure 7. The extent to which the use of patient surveys to systematically monitor patient experiences is stimulated.
Figure 8 shows that in most of the countries and regions (92%, AU, BE, CZ, DE, DK, EE, ES, ES1, ES10, ES2, ES3, ES4, ES5, ES6, ES7, ES8, ES9, FI, FR, HR, HU, IE, IT, NL, NO, PL, RO, SE, SI, SK, UK, UK1, UK2) a patient complaint mechanism for each health care organization is obligatory. In two countries a patient complaint mechamism is recommended (EL, MT) by authorative bodies, in one country (BG) it is a private initiative.
Obliged 76%
Private 0%
Recommended 19%
Not used 5%
The extent to which the provision of information about patients' legal rights is stimulated.
Obliged 30%
Private 16%
Recommended 54%
Not used 0%
The extent to which the use of patient surveys to systematically monitor patient experiences is stimulated.
28
Figure 8. Status obligation to have a patient complaint mechanism for each health care organization.
27,0% of all countries and regions (BE, BG, CZ, DK, FI, FR, LV, MT, SI, UK) have a patient complaint mechanism on national level, 27,0% on regional level (AU, EL, ES10, ES3, ES4, ES6, ES7, ES9, UK1, UK2), 27,0% on both levels (ES5, ES8, HR, IE, NL, NO, PL, RO, SE, SK) and 2,7% (HU) have a complaint mechanism that is under development. 15,8% of the countries and regions (DE, EE, EL, ES1, ES2, IT) have no patient complaint mechanism.
Table 14 gives a summary of the questions concerning patient empowerment, patient surveys and patient complaint mechanisms.
Obliged 92%
Private 3%
Recommended 5%
0%
Status obligation to have a patient complaint mechanism for each health care organization.
29
Table 14. Patient empowerment, Patient surveys, Patient complaint mechanism per country/region.
The extent to which shared decision making is stimulated.
The extent to which the provision of information about patients' legal rights is stimulated.
The extent to which the use of patient surveys to monitor patient experiences is stimulated.
Status obligation to have a patient complaint mechanism for each health care organization.
AU private obliged recommended obliged
BE recommended obliged private obliged
BG recommended private private
CZ obliged obliged obliged obliged
DE recommended obliged private obliged
DK recommended obliged obliged obliged
EE not used obliged obliged obliged
EL private not used recommended recommended
ES recommended recommended recommended obliged
ES1 obliged obliged recommended obliged
ES10 obliged obliged recommended obliged
ES2 obliged obliged recommended obliged
ES3 obliged obliged recommended obliged
ES4 obliged obliged recommended obliged
ES5 obliged obliged obliged obliged
ES6 obliged obliged obliged obliged
ES7 obliged recommended recommended obliged
ES8 obliged obliged obliged obliged
ES9 obliged obliged obliged obliged
FI obliged obliged recommended obliged
FR obliged obliged recommended obliged
HR recommended obliged recommended obliged
HU obliged obliged private obliged
IE recommended recommended recommended obliged
IT obliged obliged obliged obliged
LV obliged obliged private obliged
MT private not used recommended recommended
NL recommended obliged recommended obliged
NO obliged obliged obliged obliged
PL not used obliged private obliged
RO recommended obliged obliged obliged
SE obliged obliged recommended obliged
30
The extent to which shared decision making is stimulated.
The extent to which the provision of information about patients' legal rights is stimulated.
The extent to which the use of patient surveys to monitor patient experiences is stimulated.
Status obligation to have a patient complaint mechanism for each health care organization.
SI obliged obliged recommended obliged
SK private recommended obliged obliged
UK obliged obliged recommended obliged
UK1 recommended recommended recommended obliged
UK2 recommended recommended recommended obliged
31
CONCLUSIONS
This document describes the results of a questionnaire on quality management systems in European Member States and European Member State candidates. The goal was to collect information about the structure of the health care system in relation to quality of care and to collect information about specific activities displayed to assure and improve the quality of care in the different EU Member States. In total, 37 countries and regions returned the questionnaire (15 countries and 12 regions).
Structure of the health care system
The ultimate aim of health care systems is to maximize the potential health of individuals and populations (Øvretveit and Klazinga, 2008). To live up to this aim as well as make use of resources in the most efficient manner, health care systems need policies and leadership. Keeping health care systems on track in terms of quality and safety requires a strong sense of direction, and coherent investment in the various building blocks of the health care system (WHO, 2008). The structure of the health care system can be defined by three aspects that contribute to quality and safety of care: the service delivery structure, the financing structure and the legal structure.
The results of our questionnaire show that overall, the structure of the health care system in the EU member states (candidates) is well arranged. Almost all countries and regions indicate that they have the aspects of the service delivery structure in place, about half of the countries/regions indicate the financing structure is arranged and the legal structure is present in about 90% of the responding countries/regions. Two focal points that became apparent from the data are, that in order to further improve the structure of the health care system to contribute to quality and safety are: the publishing of national or regional reports on quality performance and the use of financial incentives related to quality and safety. This is important from a policy perspective, in order to monitor how well the various parts of the health care system are functioning and whether all the people are benefiting equally from the resources provided. In view of the continually rising costs of health care, it is also relevant to find out whether those resources are producing sufficient returns – how efficient is the health care system or specific providers within the system (RIVM, 2011, Zorgbalans). Transparent and public performance information can help patients to judge and select health care providers.
With respect to financial incentives, Øvretveit and Klazinga (2008) discuss that financing systems result in incentives and these may influence essential aspects concerning quality and safety such as the time available for a consultation, the effect of co-payment on the timeliness of visiting a physician or the extent to which certain diagnostic tests are performed or drugs are prescribed. Incentive structures vary between countries and settings but especially during the past ten years various experiments have been set up to link performance to payment (Mannion & Davies 2008, Custers et al 2008). The (financial) incentive system could be designed in such a way that it pays to deliver good quality care. For example, through legislation and regulation the purchasers of health care can be put in a position where they inherently value purchasing quality and safety alongside incentives that drive volume and cost concerns. In addition, financers can become an integral player in quality improvement by focusing on specific quality elements and set targets for providers.
Activities aimed at health care organizations
Within the health care systems, in hospitals health care is provided through a combination of professionals, medical products and technologies in an organizational setting (Øvretveit and Klazinga, 2008). Quality and safety concerns the interaction of organizations and
32
professionals with the patients that use them. In order to optimize performance of providers in terms of quality and safety, many activities can be organized and performed.
The results of the questionnaire provide insight into the degree to which 13 of these activities are used by member states (candidates) and the way in which these are organized. Contrary to the structure of the health care system, the degree to which these activities are used gives a more heterogeneous picture. Overall, all countries and regions reported the use of multiple activities, but which activities are being used differs amongst countries and regions. Almost all countries deploy activities to improve quality of care by professional licensing and professional learning programs. The use of accreditation of integrated health services, peer-review, and the re-validation of professionals are least often reported by countries and regions. These are likely more advanced activities that can only be set up when the quality management system is in a higher state of development. The level on which the activities are organized tend to be on both national and regional level, although this highly depends on the activity. In cases where the activity was organized only at one level, this tended to be national level. Not surprisingly, the activities that were organized as a private initiative were less often used/present in countries and regions as opposed to activities that were obliged.
Activities aimed at patients
Patients play an important role in health care systems since they are demanding and/or needing the services provided by professionals and organizations (Øvretveit and Klazinga, 2008, WHO, 2008). Activities aimed at patients in order to ensure or enhance quality and safety concern patient involvement, patient empowerment, patient surveys, and patient complaint mechanisms.
Overall, (a mix of) activities aimed at patients is used by the EU member states (candidates), however the degree to which the individual activities are present differs. Almost seventy percent of all countries and regions reported that patient organizations are involved in the development of policies that address quality and safety of health care provision. In sixty percent both consumer organizations and patient organizations are involved in the development of these policies. In the majority of countries and regions, the involvement of patients is organized at both national and regional level at the same time. The status that patient organizations have in their countries is in sixty percent that of an advising body and not a formal body, this is the case only in 20 percent of the countries and regions. In three quarter of the countries and regions, the provision of information on patients’ rights is obliged, and shared decision making is obliged in about half of the countries and regions. This indicated that patient involvement and patient empowerment are almost equally addressed in European Member states, but there is still to gain. The use of patient surveys to systematically monitor quality and safety of health care is in most countries recommended and obliged in one third of the countries and regions. Patient complaint mechanisms are obliged in almost all of the countries and regions and are organized on both national and regional level. In order to give patients a stronger voice, it seems that most is to gain in the involvement of patient and consumer organizations in quality and safety issues, shared decision making and the use of patient surveys.
Conclusion: using each other’s experience and knowledge
Most countries have the structures that can assure and improve quality and safety of health care in place. These structures offer the basic conditions for quality and safety of patient care. However, there is a large diversity in countries and regions when it comes to more advanced, integrated activities that are, on meso and micro level aimed at improving quality of care. The information in this report can be used by countries and regions to learn from others that do have organized those activities. Exchange of knowledge and experience can help countries to develop towards more advanced health care systems in terms of quality and safety which will ultimately lead to higher quality of care for their citizens.
33
ANNEXES
ANNEX 1 – WP6 Questionnaire. Parts 1 and 2
Part 1
Structure of the health care system
1.1 Service delivery structure Answer categories
1.1.1Does your country/region have a competent authority(ies) or body(ies) (person or organization that has the legal authority, capacity, or power to perform a designated function) responsible for quality management?
Yes / No / under development
- (IF YES) What are the responsibilities / functions of this
authority/body?
More than one answer is allowed
o Collecting information
about quality
management.
o Collecting and analyzing
information about quality
outcomes
o Education and training of
healthcare workers
o Development of quality
standards
o Identification and
dissemination of best
practices
o Development of guidelines
on patient safety
o Development of quality
management systems
o Research on quality
management
o Development of clinical
guidelines/ pathways
o Other, being [free text]
1.1.2 In your country/region, have quality standards been developed? Yes / No / Under development
- (IF YES) At what level (national, regional, other) National / Regional /Both/other namely: [free text]
1.1.3 Does your country/region publish national/ regional performance reports, including trends in the health care sector quality performance?
Yes / No/ under development
1.1.4 Does your country/region have a malpractice insurance system in place for both the public and private sector?
Yes / No / under development
- (IF YES)Is having a malpractice insurance mandatory for
getting a license?
Yes / No
1.1.5 Does your country/region have policies in place that describe the required competencies (education) for various types of professionals?
Yes / No / under development
34
1.2 Financing structure Answer categories
1.2.1 Does your country/region have specific financial incentives for healthcare organizations related to quality and/or safety?
- (IF YES) What kind of health-services do they apply to:
more than one answer is allowed
Yes / No / under development
o In-patient care
o Out-patient care
o Primary care
o Other, namely [free text]
1.3 Legal structure Answer categories
1.3.1 Does your country have legislation(s) and regulation(s) on the required training of various types of professionals practicing in health care?
Yes / No / under development
1.3.2 Does your country have legislation on and regulation to assure professional self-regulation?
Yes / No/ under development
1.3.3 Does your country have legislation on and regulation to signal and deal with professional misconduct?
Yes / No / under development
1.3.4 Does your country have legislation and regulation on patient rights?
- (IF YES) What is the scope of this information:
more than one answer is allowed
Yes / No / under development
o health information
o privacy
o informed consent
o shared decision making
35
Part 2
Activities to assure and improve quality of care
Explanation on how to fill out Part 2: In part two, we focus on both: determining what type of activities take place in each of the member states, and how parties in the health care field are stimulated to take part in these activities. To this end, three response categories are distinguished: 1 Obliged by law, decree or contract. 2 Recommended by authoritative bodies. 3 Private initiative. ad. 1 Obliged by law, decree or contract Health care organizations are obliged to apply quality management systems by third parties with controlling or sanctioning power. These obligations may be issued by law (legislation) or by decrees (for example from Inspectorates). Or these obligations may be defined by contracts with paying parties or insurers or are needed for funding. Therefore, the implementation of QMS activity is not voluntarily. ad. 2 Recommended by authoritative bodies Quality management systems are recommended by authoritative bodies without controlling or sanctioning consequences. Therefore the implementation of the QMS activity is still voluntarily. Recommendations may stem from national or regional authorities, from professional bodies or umbrella organizations, from consumer organizations or from authoritative (national) institutes. (An example are the National recommendations from the Finnish Association of Local and Regional Authorities and other parties). ad. 3 Private initiative, voluntary Health care organizations may apply the activity aimed at assuring or improving quality that is designed or organized at national or regional level voluntarily on their own initiative or individual choice (a kind of bottom-up indicatives). There is no legislation, so not sanctions will be put upon the organization in case the activity is not applied and there are no recommendations about the necessity of applying the activity by authoritative bodies.
2.1 Activities aimed at health care organizations Answer categories
Accreditation
A process that a health care institution or provider undergoes to demonstrate compliance with standards developed by an official agency or other authority.
2.1.1 Does your country/region use accreditation programmes for individual health care organizations?
Yes / No / Under development
(IF YES) Please indicate on what level these programmes are organized
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
(IF YES) Please indicate the extent to which accreditation is obliged in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
2.1.2 Is there an authority or body for the accreditation of integrated health care delivery systems (e.g. a group consisting of GP’s, hospital, nursing home, ambulatory care and home care services)
Yes / No /Under development
(IF YES) Please indicate on what level these programmes for accreditation of integrated health care delivery systems are organized
o National
o Regional
o Both national and regional
36
2.1 Activities aimed at health care organizations Answer categories
o Other, namely [free
text]……….
2.1.3 Please indicate the extent to which accreditation for integrated health delivery systems is obligatory in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative/ voluntary Audit system A process in which various disciplines work together to assess and improve the results of their activities. Audits can be internal (by members of the organization) or external (by non-members of the organization).Some systems such as ISO certification require both types of audits.
2.1.4 Please indicate the extent to which internal audits are obliged in your country
o Internal audits not used o Obliged by law, decree or
contract. o Recommended by
authoritative bodies. o Private initiative / voluntary
2.1.5 Please indicate on what level external audits are organized o Not applicable
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
2.1.6 Please indicate the extent to which external audits performed by an independent certifying authority are obliged in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
Center licensing
Authorization by a governmental or other regulatory agency that allows a health care organization to carry out its particular activities
2.1.7 Does your country use center licensing for health care organizations?
Yes / No /Under development
(IF YES) Please indicate on what level center licensing is organized
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
Clinical guidelines or pathways
A detailed description of the care practices an organization or a group of organizations provides for patients or clients with a particular diagnoses. The description has the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare and is based on the highest quality evidence and the most current data. Following the guideline or pathway is likely to result in favorable outcomes for the patient group and uses prospectively defined resources to minimize costs.
2.1.8 Please indicate on what level clinical guidelines or pathways are determined
o National
o Regional
o Both national and regional
o Other, namely [free
37
2.1 Activities aimed at health care organizations Answer categories
text]……….
o None
2.1.9 Please indicate the extent to which the use of clinical guidelines or pathways is obligatory in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary Clinical risk management
An integrated approach based on a set of standard operating procedures or practices in health care and within the institution aimed at identifying, assessing, analyzing, understanding, acting on and learning from risk issues in order to reach an optimal balance of risk, benefits and costs.
2.1.10 Do health care organizations in your country/region use clinical risk management processes?
Yes / No /Under development
(IF YES) Please indicate or what level the use of these processes is stimulated
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
(IF YES) Please indicate the extent to which health care organizations are obliged to use clinical risk management practices
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
Inspections
Periodic,targeted scrutiny of specific services, to check whether they are meeting national and local performance standards, legislative and professional requirements, and the needs of service users.
2.1.11 If your country / region has a formal body to conduct inspection visits to healthcare organizations, please indicate on what level it is active:
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
o There is no formal body
Quality indicators (performance indicators)
Formally recognised measures that assess a particular health care process or outcome that can be used to monitor, evaluate and improve the quality of patient care
2.1.12 Please indicate on what level quality indicators are determined
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
o None
2.1.13 Please indicate the extent to which the use of quality indicators is obligatory in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative/ voluntary o Quality indicators are not
used
38
2.1 Activities aimed at health care organizations Answer categories
2.1.14 Are the results on these quality indicators publically available at the hospital/facility or aggregated level?
o Yes, hospital/facility
level
o Yes, aggregated level
o Yes, both at facility and
aggregated levels
o No, not available at
either level
Quality improvement project/program
Initiatives that seek to make improvements in one or more of the six areas or dimensions of quality: (1) effectiveness, (2) efficiency, (3) accessibility, (4) acceptability, (5) equitability and (6) safety.
2.1.15 Does your country have national / regional initiatives or programs for quality improvement in health care organizations?
Yes / No /Under development
(IF YES) Please indicate on what level these programs are organized
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
(IF YES) Please indicate the extent to which health care organizations are obliged to take part in the programs
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
Professional licensing
Authorization by a governmental or other regulatory agency that allows a health care professional to carry out particular activities
2.1.16.Does your country use licensing for (at least some) health care professionals?
Yes / No /Under development
(IF YES) Please indicate on what level professional licensing is organized
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
(IF YES) Please indicate the extent to which professional licensing is obligatory in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
(IF YES) Does your country have a register of all licensed professionals
Yes / No /Under development
(IF YES) Does your country have legislation on and regulation of re-validation of professionals to assure they have the necessary up to date licence?
Yes / No /Under development
Peer review
The evaluation of performance by other people in the same field in order to maintain or enhance the quality of the work or performance in that field
2.1.17 Does your country have programs in place for peer review? Yes / No /Under development
(IF YES) Please indicate on what level is this program organized?
o National
o Regional
o Both national and regional
39
2.1 Activities aimed at health care organizations Answer categories
o Other, namely [free
text]……….
(IF YES) Please indicate the extent to which peer review activities are obligatory in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
Professional learning program on quality and safety
A program directed to health care professionals that is specifically focused on training and education about quality and safety in health care
2.1.18 Please indicate whether education and training of health care workers on quality and/or safety have been promoted in your country (in the past two years)?
Yes / No /Under development
(IF YES) Please indicate to whom have promotion activities been addressed
More than 1 answer is allowed
o Doctors
o Nurses
o Pharmacists
o Other [free text]……….
(IF YES) Please indicate whether modules on quality and safety have been included in education programs for health care professionals (undergraduate education, postgraduate education, or continuing professional education)?
Yes / No /Under development
(IF YES) Please indicate on what level these modules have been developed
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
(IF YES) Please indicate the degree to which these modules are obligatory in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
2.1.19 If the education and training of healthcare professionals on quality and safety is not fully in place yet in your country, please specify the obstacles to a full implementation
More than 1 answer is allowed
o No consensus on its contents
o Not enough resources available
o Required technology is not available
o Required infrastructure is not available
o Required expertise is not available
o Cultural barriers o Other [free text]……….
Self evaluation system A process for looking at one's own health care organizations’ progress, development and learning with respect to quality and safety to determine what has improved an what areas still need improvement ( The business dictionary).
2.1.20 Please indicate the degree to which self evaluation is obliged in your country
o Obliged by law, decree or
contract. o Recommended by
authoritative bodies. o Private initiative / voluntary
40
2.1 Activities aimed at health care organizations Answer categories
o Not obliged
2.1.21 Please indicate on what level criteria for self evaluation are developed
o Not applicable
o National
o Regional
o Both national and regional
o Other, namely [free
text]……….
2.2 Activities aimed at patients Answer categories
Patient involvement
The extent to which patients and their families or caregivers, whenever appropriate, participate in decisions related to their condition (e.g. through shared decision-making, self-management) and contribute to organizational learning through their specific experience as patients (including, for example, patient reporting of adverse events or participation in Root Cause Analysis related to their care). Collective patient/public involvement is the extent to which patients and citizens, through their representative organizations, contribute to shaping the healthcare system through involvement in healthcare policy-making.
2.2.1 Please indicate whether patients’ or citizens/consumers’ organizations are involved in the development of quality and/or safety policies and programs in your country
(IF YES) Please indicate which?
Yes / No /Under development
o Patient organizations
o Consumer organizations
o Both patient and consumer
organizations
o Other, namely [free text]
(IF YES) Please indicate on what level these organizations are involved
o National
o Regional
o Both national and regional
o Other, namely [free text]….
(IF YES) Please indicate what status these organizations have as partners in the development of policies and programs
Formal partner
Advising body
Other, being [free text]
2.2.2 In which of the following activities are individual patients/citizens and/or patient or citizens/consumers’ organizations involved?
More than one answer is allowed
o development of quality criteria/standards
o design of protocols/standards
o evaluation of quality improvement projects
o participation in (quality) committees
o participation in improvement projects
o discussion of results of patient surveys, handling of
41
2.2 Activities aimed at patients Answer categories
complaints etc. o other, namely [free text]…..
… o Individual patients or patient
organizations are not involved.
2.2.3 Please indicate the extent to which patient / client rights are addressed in your country?
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative/voluntary o Patient rights are not
addressed 2.2.4 Please indicate what kind of mechanism(s) is/are available concerning patient/ client feedback More than 1 answer is allowed
o Complaint mechanism. o Broad feedback system o Other, namely…[free text].
2.2.5 Please indicate the extent to which patient / client participation in health care organizations has been addressed concerning trusted representatives (the person who can represent the patient when the medical condition of the patient / client requires this , for example a family member or friend).
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary o Patient participation is not
addressed
Patient empowerment
A multi-dimensional process that helps people gain control over their own lives and increases the capacity of people to act on issues that they themselves define as important.
A process through which individuals and social groups are able to express their needs, present their concerns, devise strategies for involvement in decision-making, and take political, social and cultural action to meet those needs
2.2.6 Please indicate the extent to which shared decision making is stimulated in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative/ voluntary o not used
2.2.7 Please indicate the extent to which the provision of information about patients’ legal rights is stimulated in your country
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative/ voluntary o not used
Patient surveys
The systematic gathering of a sample of data on patient satisfaction or patient experiences that is considered to be representative of a whole. The data is based on the perceptions of patients
2.2.8 Please indicate the extent to which the use of patient surveys in order to systematically monitor patient experiences is stimulated in your country.
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative/voluntary o Not used
42
2.2 Activities aimed at patients Answer categories
Patient complaint mechanism
A formal body that a patient can turn to express perceived dissatisfaction about care services received (WP6)
2.2.9 What status has the obligation to have a patient complaint mechanism for each healthcare organization?
o Obliged by law, decree or contract.
o Recommended by authoritative bodies.
o Private initiative / voluntary
o None
2.2.10 Please indicate whether your country has a patient complaint mechanism on other levels than that of the health care organization
o Yes, national level
o Yes, regional level
o Yes, both levels
o Yes, other namely [free
text]…
o No
43
ANNEX 2 – PaSQ Glossary and WP6 Conceptual Framework
Table 1. General PaSQ concepts and key aspects
Concepts and definitions Key aspects of the concepts
Clinical Risk Management (ClinRM)
An integrated approach based on a set of Clinical Risk Management Practices aimed at identifying, assessing, analysing, understanding, acting on and learning from risk issues in order to reach an optimal balance of risk, benefits and costs.
(PaSQ; WP4 & WP6, based upon ISO 31000, http://www.praxiom.com/iso-31000-terms.htm
Activities and methods for
Identification of possible risk and harm
Prevention of possible risk and harm
Detection/monitoring of risk and harm
Reduction of possible risk and harm
Incident recovery
System resilience
(PaSQ; WP4, WP6)
Exchange Mechanism (EM)
Mechanism for sharing, learning and exchanging information, knowledge, skills, and experiences related to Patient Safety Good Clinical Practices and Good Organisational Practices. The exchange mechanism provides opportunity for learning about Patient Safety Good Clinical Practices and Good Organisational Practice.
(PaSQ; WP4, WP5, WP6)
Exchange can take place through e.g.:
Meetings
Study tours
Placements
Workshops
Twinnings
Technical assistance
Expert master classes
On-line courses
(PaSQ; WP4, WP5, WP6)
Health Care (HC)
Health care is services received by individuals or communities to assess, promote, maintain, monitor, or restore their health.
(Based upon the World Health Organization, World Alliance for Patient Safety. Conceptual Framework for the International Classification for Patient Safety Version 1.1. Final Technical Report. Geneva: World Health Organization.2009 and the Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare)
Public health services
Personal medical services
(PaSQ; WP4, WP5, WP6)
Health Care System (HCS)
A health care system is a set of activities and actors whose principal goal is to improve health through the provision of public health and personal medical services.
(Based upon the OECD Health Working Papers No. 23 Health Care Quality Indicators Project Conceptual Framework Paper. Organization for Economic Co-operation and Development. 2006)
A good health system delivers quality services to all
Robust financing mechanism
Well trained and adequately paid
workforce
Reliable information as basis for
decisions and policies
Well-maintained facilities and logistics
(PaSQ; WP4, WP5, WP6)
44
Concepts and definitions Key aspects of the concepts
people, when and where they need them. The exact configuration of services varies from country to country, but in all cases requires a robust financing mechanism; a well-trained and adequately paid workforce; reliable information on which to base decisions and policies; well-maintained facilities and logistics to deliver quality medicines and technologies.
(World Health Organization, 2010. Health Systems. [Online] Available at: http://www.who.int/topics/health_systems/en/ [Accessed 12-10-2012, WHO, 2010])
Patient Empowerment (PE)
A multi-dimensional process that helps people gain control over their own lives and increases the capacity of people to act on issues that they themselves define as important.
(Luttrell et al. (2009), Understanding and operationalising empowerment. Overseas Development Institute working paper.)
A process through which individuals and social groups are able to express their needs, present their concerns, devise strategies for involvement in decision-making, and take political, social, and cultural action to meet those needs.
(Deepening our Understanding of Quality improvement in Europe; http://www.duque.eu/)
Patient empowerment aspects are:
Information to patients/citizens
Informed consent
Shared decision-making/concordance in
clinical practice
Inviting patients views – feedback loop
An enabling health care environment
Training/education of health
professionals
(PaSQ; WP4, WP6)
Patient Involvement (PI)
The extent to which patients and their families or caregivers, whenever appropriate, participate in decisions related to their condition (e.g. through shared decision-making, self-management) and contribute to organisational learning through their specific experience as patients (e.g. patient reporting of adverse events or participation in root cause analysis related to their care).
Collective patient/public involvement is the extent to which patients and citizens, through their representative organisations, contribute to shaping the health care system through involvement in health care policy-making.
(European Patients Forum for PaSQ, adapted from the Value+ project: http://www.eu-patient.eu/Initatives-Policy/Projects/EPF-led-EU-Projects/ValuePlus/)
Patient involvement aspects are:
Access to information
Education/health literacy
Participation in organisational learning
activities
Patient experiences
Patient involvement in health care
decision-making
Patient rights
Patients/citizens’ involvement in shaping
health care policy, organisation and
delivery
Levels of involvement:
1. Consultation; often asking for
information from service users.
2. Collaboration; sharing of decisions,
often equalising power. Most
genuine involvement tends to be at
this level.
3. User-led; full control and power to
service users, consultation with
45
Concepts and definitions Key aspects of the concepts
professionals.
(PaSQ; WP4, WP5, WP6)
Patient Safety (PS)
Patient safety is the reduction of the risk or harm associated with health care to an acceptable minimum. An acceptable minimum refers to the collective notions of i) given current knowledge, ii) resources available and iii) the context in which care was delivered, weighed against the risk of non-treatment or other treatment.
(Based upon the World Health Organization, World Alliance for Patient Safety. Conceptual Framework for the International Classification for Patient Safety Version 1.1. Final Technical Report. Geneva: World Health Organization.2009)
A continuous learning and improvement cycle emphasising:
Methods
Application of Plan-Do-Study-Act and/or
other cyclical approaches to safety
improvement
Education and continuous training in
patient safety
Use of retrospective and proactive
clinical risk management practices for
safety improvement e.g. reporting and
learning systems
Sharing of knowledge, skills and
experiences
Implementation of patient safety
initiatives/activities/campaigns
Conceptual aspects
Safety as a dimension of quality of care
Awareness of organisational systems
science
The processes of reflection and
accumulation of knowledge
Consideration of contextual implications
Focus on the patient(s)/citizens
Developing a safe patient safety culture
Human factor aspect
System resilience
(PaSQ; WP4, WP5, WP6)
Quality of Care (QoC)
The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.
Quality of care means that a health system should seek to make improvements in six areas or dimensions of quality: (1) effective, (2) efficient, (3) accessible, (4) acceptable, (5) equitable, and (6) safe.
(Quality of Care: A process for making strategic choices in Health systems, WHO 2006)
Quality Dimensions:
Effective
Efficient
Accessible
Acceptable (patient centeredness)
Equitable
Safe
(PaSQ; WP4, WP6)
46
Table 2. Concepts and key aspects relevant for Good Organisational Practices in Quality
Management Systems
Concepts and definition Key aspects of the concepts
Patient Safety System
Emphasis is placed on the system of care delivery that (1) identifies risk and errors; (2) learns from the errors that do occur; (3) takes action to prevent similar errors reoccurring, and (4) is built on a culture of safety that involves health care professionals, organisations, and patients.
(PaSQ; WP6)
Key methods for clinical risk management;
Root cause analysis of
incidents/adverse events
Failure Mode Effect Analysis (FMEA)
Prospective risk analysis
Pro-active patient safety culture
Continuous improvement based on
feedback of result
(PaSQ; WP6)
Quality Dimensions (QD)
Effective: delivering health care that is adherent to an evidence base and results in improved health outcomes for individuals and communities, based on need.
Efficient: delivering health care in a manner which maximises resource use and avoids waste.
Accessible: delivering health care that is timely, geographically reasonable, and provided in a setting where skills and resources are appropriate to medical need.
Acceptable (patient centeredness): designing and delivering health care which responds to and meets the needs, preferences, and aspirations of individual service users and the cultures of their communities. Furthermore, delivering health care which takes into account the preferences and aspirations of the individual service users and the cultures of their communities; it encompasses the concepts of patient involvement and promotes a culture of kindness, consideration, and respect for those using the service.
Equitable: delivering health care which does not vary in quality because of personal characteristics such as gender, race, ethnicity, geographical location, or socioeconomic status.
Safe: delivering health care which minimises risks and harm to service users.
(Based upon Quality of Care: A process for making strategic choices in Health systems, WHO 2006)
Quality Management System (QMS)
A set of interacting activities, methods, and procedures used to direct, control, and improve the quality of care. In developing and implementing quality management systems leadership and resources available play a significant role.
Responsibilities of stakeholders are
addressed
Procedures for process management
47
Concepts and definition Key aspects of the concepts
(Deepening our Understanding of Quality improvement in Europe; http://www.duque.eu/ 2008)
Human resource management
Education, training and continuous
professional development of technical
and non-technical skills
Leadership commitment
Analysis and monitoring (including
measurement, performance evaluation,
continuous improvement)
Patient involvement
(PaSQ; WP6)
Transferable Good Organisational Practices in Quality Management Systems
Plans, strategies, or programs at national or regional level (encompassing structure and process) oriented to improve the quality of health care that can be useful for other health care systems at different levels.
(PaSQ; WP6)
Figure 1. Conceptual Framework for Good Organisational Practices in Quality Management Systems
49
Table 3. Definitions of Activities in the Conceptual Framework for Good Organisational Practices in Quality Management Systems
Concepts and definitions
Accreditation
A process that a health care institution or provider undergoes to demonstrate compliance with standards developed by an official agency or other authority.
(The free dictionary).
Audit System
A process in which various disciplines work together to assess and improve the results of their activities. Audits can be internal (by members of the organisation) or external (by non-members of the organisation). Some systems such as ISO certification require both types of audits.
(PaSQ; WP6).
Center Licensing
Authorisation by a governmental or other regulatory agency that allows a health care organisation to carry out its particular activities.
(The free dictionary).
Clinical Guidelines or Pathways
A detailed description of the care practices an organisation or a group of organisations provide for patients or clients with a particular diagnosis. The description has the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of health care, and is based on the highest quality evidence, and the most current data. Following the guideline or pathway is likely to result in favorable outcomes for the patient group and uses prospectively defined resources to minimise costs.
(The free dictionary).
Clinical Risk Management
An integrated approach based on a set of Clinical Risk Management Practices aimed at identifying, assessing, analysing, understanding, acting on and learning from risk issues in order to reach an optimal balance of risk, benefits and costs.
(PaSQ; WP4 & WP6, based upon ISO 31000, http://www.praxiom.com/iso-31000-terms.htm)
Incident Reporting and Learning System
A system which requires clinical staff to report all matters relating to patient care where there has been
an unexpected circumstance, which could have caused or did cause unnecessary harm to the patient,
to avoid their repetition.
(PaSQ; WP6)
Inspections
Periodic, targeted scrutiny of specific services, to check whether they are meeting national and local performance standards, legislative, and professional requirements, and the needs of service users.
(The free dictionary).
Patient Complaint Mechanism
A formal body or established process that a patient can turn to express perceived dissatisfaction about care services received.
50
Concepts and definitions
(PaSQ; WP6).
Patient Surveys
The systematic gathering of a sample of data on patient satisfaction or patient experiences that is considered to be representative of a whole. The data is based on the perceptions of patients themselves.
(PaSQ; WP6).
Peer Review
The evaluation of performance by other people in the same field in order to maintain or enhance the quality of the work or performance in that field.
(The free dictionary).
Professional Learning Program
A program directed to health care professionals that is specifically focused on training and education about quality and safety in health care.
(PaSQ; WP6).
Professional Licensing
Authorisation by a governmental or other regulatory agency that allows a health care professional to carry out particular activities.
(The free dictionary).
Quality Improvement Project/Program
Initiatives that seek to make improvements in one or more of the six areas or dimensions of quality: (1)
effectiveness, (2) efficiency, (3) accessibility, (4) acceptability, (5) equitability and (6) safety.
(PaSQ; WP4, WP6).
Quality Indicators/Performance Indicators
Formally recognised measures that assess a particular health care process or outcome that can be used to monitor, evaluate and improve the quality of patient care.
(The free dictionary).
Self-Evaluation System
A process for looking at one’s own health care organisation’s progress, development and learning with respect to quality and safety to determine what has improved and which areas still need improvement.
(The business dictionary).