3.2 Quality Management
3.2.1 Quality Management in the healthcare sector
In the last years different quality standards and systems as well as “best practice models” have been developed and established in the healthcare area.
This section will give an overview on some selected international quality stand-ards and systems used in healthcare:
Quality Management – ISO 9000 family
Standard for Healthcare Services 6 - EN15224:2012
QEP 7 (Quality and Development in Doctor’s Surgery)
5 DIN EN ISO 8402: Quality management and quality assurance -Vocabulary
6 ÖNORM EN 15224: Healthcare services - Quality management systems - Requirements based on EN ISO 9001:2008
7 QEP = Qualität und Entwicklung in Praxen® (Quality and Development in Doctor’s Surgery)
KTQ8 (Cooperation for transparency and quality in healthcare)
EFQM9 (European Foundation for Quality Management)
EPA10 (European Doctor’s Surgery Assessment)
DRG11 (Diagnosis-related group)
Quality Management – ISO 9000 family
ISO 9000 standard is the standard of Quality Management par excellence: “The ISO 9000 family addresses various aspects of Quality Management and con-tains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is con-sistently improved”, (ISO 12).
Following standards are included in the ISO 9000 family:
ISO 9000:2005 - covers the basic concepts and language
ISO 9001:2008 - sets out the requirements of a Quality Management system
ISO 9004:2009 - focuses on how to make a Quality Management sys-tem more efficient and effective
ISO 19011:2011 - sets out guidance on internal and external audits of Quality Management systems
Today ISO 9001 standard is one of the most widely used management tools in the world. “ISO 9001:2008 sets out the criteria for a Quality Management system and is the only standard in the family that can be certified to (although this is not a requirement)”, (ISO12). It can be used by any organization, large or small, re-gardless of its field of activity”, (ISO12), (EN ISO 9001, 2008). Now with the up-dated standard ISO 9001:2015 Risk Management became one of the main parts within this standard.
8 KTQ - Kooperation für Transparenz und Qualität im Gesundheitswesen (KTQ): www.ktq.de
9 EFQM - European Foundation for Quality Management, www.efqm.org
10 EPA – Europäisches Praxis Assessment / European Doctor’s Surgery Assessment;
www.europaeisches-praxisassessment.at, http://www.europaeisches-praxisassessment.de
11 DRG - Diagnosis-related group, https://en.wikipedia.org/wiki/Diagnosis-related_group
12 ISO - International Organization for Standardizatio, www.iso.org/iso/iso_9000, last visit 2014-10-07
Table 1 highlights some strengths and weakness of the ISO 9000 and IOS 9001 according to the healthcare area (hospitals/in clinical practice, doctor’s surger-ies/in private practice):
Strengths Weakness
It is very structured.
The handbook structure is distinguishable.
It is internationally accepted.
The concept requires a self-assessment (internal audit) whereby a constant control on the effectiveness and efficien-cy of the regulation is taken.
It is kept very general.
There are less concrete starting points related to doctor’s surger-ies. This requires paraphrases.
As a result for a doctor’s surgery the fulfilment of the requirements is problematical and very time-consuming.
Table 1: ISO 9000, ISO 9001 - strengths and weakness, based on (Knopp &
Knopp, 2010)
Healthcare services – ÖNORM EN 15224
A standard, especially for Quality Management systems for healthcare, was published in 2012. “The requirements in this standard incorporate those from EN ISO 9001:2008 with additional interpretations and specifications for healthcare”, (ÖNORM EN 15224, 2012).
“To be able to define and describe the quality in healthcare the quality character-istics need to be identified and described. A quality characteristic always relates to a quality requirement”, (ÖNORM EN 15224, 2012). Thus eleven quality char-acteristics of healthcare services with interrelated quality requirements were identified, where one is patient safety.
Eleven quality characteristics of healthcare services 01 appropriate, correct care
02 availability 03 continuity of care 04 effectiveness 05 efficiency
06 equity
07 evidence/knowledge based care
08 patient centred care including physical, psychological and social integrity
09 patient involvement 10 patient safety
11 timeliness/accessibility
Table 2: Eleven quality characteristics of healthcare services with interrelated quality requirements, according to (ÖNORM EN 15224, 2012)
In most countries representatives of healthcare professionals support healthcare facilities (e.g. hospitals, residential care home, etc.), and doctor’s surgeries to implement and improve Quality Management.
QEP - Quality and Development in Doctor’s Surgery
For example in Germany the Association of Statutory Health Insurance Physi-cians13 and the National Association of Statutory Health Insurance Physicians14 developed the so called QEP model especially supporting doctor’s surgeries at their implementation of Quality Management. In the QEP 2010, revised edition 2012, there are 144 quality targets defined and for their operationalisation 270 different indicators are mentioned (Diel & Gibis, 2013). The 63 core targets are divided into 18 divisions and 5 chapters15, where patient safety is one out of them. The 5 chapters consist of patient-centred care, patient rights and patient safety, employees and qualification, management and organisation, and quality development. Those core targets compose the code of practice for the structur-ing (Knopp & Knopp, 2010). As part of the QUP, proofs are equal to indicators.
Therefore QUP requires only the following findings (Knopp & Knopp, 2010):
proof is met
proof is not met
proof is not applicable
Table 3 points out the strengths and weakness of the QEP method.
13 Kassenärztlichen Vereinigungen (KV)
14 Kassenärztliche Bundesvereinigung (KBV)
15 QEP – 5 chapters: patient services, patient rights and patient safety, employees and qualifica-tion, leadership and organisaqualifica-tion, quality development (Diel & Gibis, 2013)
Table 3: QEP - strengths and weakness, according to (Knopp & Knopp, 2010)
KTQ - Cooperation for transparency and quality in healthcare
One further healthcare standard has been established by the Cooperation for Transparency and Quality in Healthcare (KTQ17) in Germany. Any medical facili-ty in Germany, Austria and Switzerland (DACH-Region) has the possibilifacili-ty to get certified by this quality standard. KTQ is a self-assessment model and the main target of the KTQ certification is to optimize patient care processes ( (Ennker, Pietrowski, & Kleine, 2007), (Knopp & Knopp, 2010), KTQ17).
The methodology describes the criteria for Quality Management, which is divid-ed into six KTQ-categories17:
patient-orientation
employee-orientation
safety
communication and information
leadership
16 G-BA – Gemeinsamer Bundesausschuss (Federal Commission)
17 Kooperation für Transparenz und Qualität im Gesundheitswesen (KTQ): www.ktq.de
Strengths Weakness
The QEP method has been de-veloped and written from doc-tors for docdoc-tors.
The proof of a requirement is equal to an indicator. The result of this is no need for an elabo-rate evaluation compared to any other method.
The core targets achieve the requirements of the federal commission (G-BA16) on the QM concept for a doctor’s surgery.
According to long explanations of the core targets and the com-plicated wording, it is often hard for the medical staff to handle sin-gle-proof documents, which are not related to a superordinate instrument except for the core target number.
Quality Management
The KTQ method is comparable to the EFQM method by the European Founda-tion for Quality Management18 (Ennker, Pietrowski, & Kleine, 2007), (Knopp &
Knopp, 2010).
Table 14 illustrates strengths and weakness of the KTQ method in hospitals and doctor’s surgery.
All relevant processes of a hos-pital or the doctor’s surgery are considered.
KTQ provides hardly structured guidelines. The handbook as navigation instrument is miss-ing.
Different assessment tech-niques require additional train-ings and learning-processes.
The assessment itself is very extensive.
The self-assessment can lead to an apparent objectivity.
Table 4: KTQ - strengths and weakness, based on (Knopp & Knopp, 2010)
EFQM - European Foundation for Quality Management
The EFQM Excellence Model was established in 1988 by European enterprises (EFQM19). “The EFQM Excellence Model provides a framework that encourages the cooperation, collaboration and innovation that we will need to ensure this
19 EFQM - European Foundation for Quality Management, www.efqm.org
20 www.efqm.org/the-efqm-excellence-model, retrieved 2014-10-06
Figure 4: EFQM-Excellent-Model - the Model Criteria (EFQM21)
The EFQM Foundation was formed to recognise and promote sustainable suc-cess and to provide guidance to those profit and non-profit organisations seek-ing to achieve it (EFQM20). “This is realised through a set of three integrated components, which comprise the EFQM Excellence Model (EFQM20):
The Fundamental Concepts of Excellence
The Model Criteria
The RADAR Logic
Below table highlights some strengths and weakness of the EFQM Excellent regarding to the healthcare of clinical domains and physicians in private practic-es domains:
21 EFQM – Model Criteria, http://www.efqm.org/efqm-model/model-criteria, retrieved 2014-10-07
Table 5: EFQM - strengths and weakness, based on (Knopp & Knopp, 2010)
Based on the initiative of German doctors, the “QP- Qualitätspraxen GmbH22”, a composite of interested and committed doctors, was established in 1998 with the target to implement the EFQM Excellence Model into the doctor’s surgeries (Knopp & Knopp, 2010). The concept is based on a descriptive modular setup of the EFQM model. At least it is a conglomerate of the previously mentioned standards (Knopp & Knopp, 2010):
ISO: use of internal audits
QEP, EPA: e.g. complex of questioning
KTQ: implementation of the Deming Cycle As a result a mutual exchange of documents is possible.
EPA - European Doctor’s Surgery Assessment
The basis of the EPA concepts consists of 5 domains (infrastructure, humans, information, finances, quality, safety), subdivided into 26 dimensions with 168 indicators and 413 items (Knopp & Knopp, 2010).
Strengths and weakness of the EPA concept are summarized in Table 6.
22 QP-Qualitätspraxen GmbH, http://www.qualitaetspraxen.de/ueber-uns, retrieved 2014-09-29
Strengths Weakness
The self-assessment differenti-ates between strengths and room for improvements. This can result in continuous further work.
The model is not designed spe-cifically for the healthcare area (clinical domain, private practic-es domains).
The description is of limited use for clinical areas and doctor’s
Table 6: EPA - strengths and weakness, based on (Knopp & Knopp, 2010)
DRG - Diagnosis-related group
The DRG is a system to classify hospital cases into one of originally 467 groups, so it is used for categorisation of diseases.
At least, the original objective of DRG was to develop a classification system that identified the "products" that the patient received. Since the introduction of DRGs in the early 1980s, the healthcare industry has evolved and developed an increased demand for a patient classification system that can serve its original objective at a higher level of sophistication and precision (Baker, 2002). The objective of the DRG system had to expand in scope to meet those evolving needs. Today, there are several different DRG systems available and in use, whereas most of the systems have been developed in the US.
Such systems could help when it is necessary to define categories and subcate-gories for contributory factors as required and used in the proposed HFdFMEA model.