1.1.02 Quality and compliance policy for the hospital

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1 Purpose and objective

The hospital's commitment to a quality standard and a claim class. Orientation towards a quality management system and the verification procedure.

Explanation of normative requirements (laws, regulations, directives, guidelines)

Consistent level of quality every day of the week.

Uniform quality level of services

Provision of treatment options according to urgency

Ethical principles in the provision of care, such as non-discrimination, equal treatment for equal needs.

Identification of physical, linguistic, cultural or other barriers to the provision of services and their avoidance when making decisions in individual cases and organising processes in general.

Respect for personal values, attitudes and religious beliefs

Respect for privacy and assurance of confidentiality (medical confidentiality)

Explanation of operational and business matters, including marketing, admission and dismissal conditions, shareholding structure

Treatment is of the same quality, regardless of the financing of the treatment.

Disclosure of business and professional conflicts of interest

Explanation of professional duties.

2 Scope of application

In the context of counselling for the development of quality systems. During the consultation, the purpose of establishing a quality policy, the appropriate scope and some important statements should be presented and discussed.

3 Description

3.1 Idea of the element

The hospital's quality policy should be set out in a document. The quality policy should be formulated as a text and formally adopted by the management or, better, by the "top management" (this will usually be the hospital's owner). The statements in the document should be relevant to the objectives of the issuing hospital and to the expectations and requirements of its named "customers".

The document should be made known to all employees. The management should ensure that the statements are understood by all employees.

The quality policy should provide answers to the following questions:

• Who does the hospital think it is there for? Who is the target person (the "customer") in the sense of the task? "Customers" in this sense can be: individuals, groups formed in terms of time and place, institutions or conceptual groups such as "society as a whole".
• What are the requirements of these "customers"? Are they possibly fixed or presupposed? If so, where? If they are not yet defined: How do we find out what the requirements are?
• Which tasks can be found in the respective state hospital plans
• Are we prepared to clearly define or allow the requirements of our task (our services and the provision of our services) to be defined in the form of perceptible and assessable qualitative and quantitative characteristics?
• In what way have we convinced ourselves that the describable and measurable characteristics and features of our services are suitable to fulfil the requirements?
• What are our intentions and objectives for the comprehensive organisation of the hospital and its services?
• How are responsibilities assigned in the pursuit of objectives?

3.2 What needs to be done?

The text is initially formulated as a continuous text, possibly with chapter headings or subdivisions. The quality policy begins with a brief introduction that summarises the corporate concept or the hospital's mission and establishes the relationship to a corporate group or other superordinate organisational structure.

3.3 Claim classes

As the choice of claim class is very closely linked to the corporate concept, it should be categorised and justified here. The claim class will play a role in all further statements in the quality policy.

- World standard
- Regional significance
- Hospital for central, specialised, basic and standard care.

This is followed by statements on the quality policy, possibly with reference to recognised standards, possibly broken down by management responsibility, position in relation to employees, "customers", other partners and the specific area of work.

3.4 Short formula

The text can later be used to summarise short theses, principles, rules, commandments or goals in the sense of a mental compression. They can be used as posters, brochures, etc. When communicating the transformation process, further compression into a short formula is particularly valuable, e.g: Let's make things better (Philips) "We have understood" (Opel for their environmental policy)

Example of quality policy (university hospital)

3.4 Description of the facility:

A hospital as part of the university, where research and teaching also take place? A university department that runs a hospital? A research centre where teaching and treatment take place? A hospital where experimental and innovative methods are part of "normal operations"?

The statement "unity of research, teaching and hospital" must be filled with content so that more is said about the three areas of work than that they are connected in an undefined way (which is a triviality). We are interested in how the three elements relate to each other (are organised, influence each other, are interdependent).

Example "Management responsibility"

The top management bears undivided responsibility for achieving the hospital's goals. The main tasks of the management will be: to integrate the services of the hospital into the services of the university (planning and coordination of the overall concept) and to form the strategic alliances necessary to fulfil the overall task, to achieve a high degree of coordination of services between the departments (consensus building in the faculty). to observe the close connection between research, teaching and patient care despite all independence. To follow generally acceptable rules when introducing innovative methods (design responsibility).

In order to fulfil its responsibility, the management takes the following measures:

3.5 Identification of priority intentions

Satisfy "customers" in compliance with professional standards and ethics by clearly defining and exploring customer requirements and formulating them clearly. Continuously review quality requirements, processes and their outcomes through measurement and control to identify opportunities for improvement. Preventive measures to exclude complications, undesirable side effects and risks. Consideration of social and environmental requirements in order to prevent adverse effects on society and the environment. Optimise the benefits of providing the services (efficiency, cost-effectiveness), also with regard to the class of requirements. To harmonise the overall range of services in such a way that they can be provided in terms of the type, number and nature of rooms, equipment and personnel deployment in line with capacity and time. The management declares that it will observe the principles of proper environmental protection in the procurement, use and disposal of products, in construction measures and in the consumption of energy, water, air, soil and other materials. In particular with regard to emissions and waste, risks to the environment must be ruled out.

3.6 Establishment of a QM system

In order to fulfil this responsibility, the management establishes a structured QM system for the effective control, evaluation and improvement of service quality during all stages of service provision.
- Personnel with specific responsibility for maintaining and reviewing the QM system and individual test steps are deployed.
- a formal periodic independent internal review is carried out by these personnel to determine whether all elements of the QM system have been realised and are effective. The result is formally reported to the management.
- The QM system is continuously assessed and analysed for potential improvements.
- The QM system is checked by these personnel to see whether changes brought about by new technologies, quality concepts, market strategies, social demands or environmental conditions have been incorporated into the QM system.
- the suitability of individual services to fulfil the quality requirements is presented.

3.7 Presentation of the management principles

The management recognises that the fulfilment of the tasks is based on the interaction of those responsible, the personnel, the resources used and the QM system. The primary task here is to create the conditions under which employees can perform at their best. This includes - that the employees can do their best under the given conditions and that the cause of problems is to be sought in the organisation and the processes.
- that employees at all levels need to have their commitment, ideas and suggestions recognised.
- that the necessarily co-operative nature of work in the hospital is based on mutual trust and recognition. The boundaries between professional groups and departments should be abandoned in favour of a supplier-customer relationship, the nature of which needs to be understood.
- that employees need support, especially when they take on responsibility and thus personal risks.
- that employees need career prospects within the hospital and beyond.
- that the relationship between the departments and with the management is based on partnership and federalism. The connection is based on common goals, the tasks assumed for this purpose and the values respected by all.
- that decisions are made on the basis of dialogue, consensus and an interdisciplinary approach. - that tasks, competences and responsibilities are clearly defined.
- that the decision-making channels (procedures) are transparent for everyone.
- that evaluating the processes in the departments and the jointly produced results is a prerequisite for recognising the need for improvements and implementing them.
- that the organisational structure and processes are planned for the long term and continuously developed on the basis of strategic considerations.

Example "Position of employees"

The hospital sees its employees as the decisive force in the fulfilment of its diverse tasks.
The hospital sees its task as ensuring the livelihood of its employees through performance-related pay and job security. Creativity, flexibility and personal initiative are to be encouraged by creating attractive jobs and employment conditions, promoting junior staff and providing opportunities for further training, extensive participation rights within the framework of clear competences and responsibilities. Quality awareness should be based on the conviction that goals will be achieved within the bounds of what is possible. Hospital employees must ensure that they are competent, reliable and accurate in the fulfilment of their tasks. The execution must be complete, correspond to the state of the art and be credibly communicated to the patient at all times. Staff should be courteous, approachable and accessible to patients' expressed wishes and needs. Staff should also be aware of wishes and problems that are often not expressed and be prepared to deal with them. A statement on occupational health and safety should not be missing here.

Example "Partnership of interests"

The management and staff of the hospital are aware that comprehensive fulfilment of the tasks is only possible if the interests of the partners involved in this task are recognised and respected. These include the referring doctors, the cost bearers, the public health authorities, other hospitals and other therapeutic facilities such as rehabilitation centres, care services and self-help groups.

Example "Scope of medical care"

What target group has the hospital identified for its services?
Are patients from the neighbourhood, from the region treated? What is the distribution? Is "all" medicine offered or are there specialisations? In terms of specialisation or intensity (e.g. intensive care, particularly expensive treatments, only innovative treatments)? The mission in patient care is seen as providing help to patients who turn to the hospital as far as it can be provided with the hospital's resources (patient well-being is preferable to the term patient satisfaction). The hospital will always pay attention to this:
- the dignity of patients, their freedom in the choice of means and personal responsibility.
- their need for information and an atmosphere of safety and security.
- Despite all the empathetic human sympathy, they must respect their personal sphere, their religious and cultural idiosyncrasies and personal sensitivities.
- Ongoing, coordinated care - Confidentiality and protection of information that patients have provided to the hospital (data protection).
- taking relatives seriously in their concern and responsibility for the patient's fate. - The involvement of the referring doctors in an overall therapeutic concept, their responsibility for the patient and co-operation with them.

• The hospital services should be provided insofar as the number and qualifications of the employees, the operating resources and the materials are suitable and their capacity is sufficient.
• They should be appropriate in terms of time, quantity and situation (e.g. the waiting and expiry time should be appropriate).
• Clinical decisions must be made with regard to the patient's presumed best interests, to the best of our knowledge and belief, without external influences.
• They should not be restricted by social status, nationality, denomination, religion or gender.
• The treatment of individual patients should be under the recognisable responsibility of a doctor who brings together (integrates) the specialised services (comprehensively, holistically).
• * The hospital services should have proven themselves in experience based on scientific methods and correspond to social standards.
• * The services should be provided under appropriate hygienic and safety conditions. The safety requirements also apply under the extreme conditions of emergency or intensive care treatment.
• The burden on patients due to pain, uncertainty about the course of the disease and the unfamiliarity of people and surroundings should be kept as low as possible.
• Recognising socio-political necessities, services should be provided efficiently (cost-consciously, economically, using limited resources in a performance-oriented manner). In order to safeguard the principle of solidarity, sensible paths of economic efficiency must be pursued.
• The provision and results of hospital services must be subject to a qualitative and quantitative review of their characteristics and characteristic values.

Professional duties

The hospital's quality policy must not conflict with the duties of the professions that work in the hospital. Professional obligations are not only derived from legal regulations, but also from professional documents. The hospital operator would put its employees in serious conflict if its quality policy were to contradict these principles. As an example, Appendix 1 summarises the professional duties of doctors from various documents. The list is not exhaustive.

4 Documentation

The counselling is documented in the brief minutes of the counselling sessions. The documentation of a company's quality policy is set out in the quality manual.

5 Time required

The explanation of the concept of the quality policy requires approximately one working day, which should be spent in an undisturbed atmosphere with those responsible. In most cases, the initial requirements and objectives of the hospital can already be worked out using the examples, which then form the basis of the quality policy. The formulation of the quality policy can take many months with the necessary discussion process. If a written corporate concept is not yet available, the time required for this must be added.

6 Notes and comments

6.1 Confusion with business concept

The quality policy must not be confused with the hospital's corporate concept. The general corporate objectives (the corporate concept, the corporate policy) go beyond the quality policy. The hospital can, for example, take on tasks in preventive healthcare, see itself as part of a healthcare system, as an economically prosperous company or as a research institution or training centre that also treats patients in order to fulfil its mission, as an emergency facility or as an inpatient hospital. Do you want to provide comprehensive care for the population or do you want to operate a health centre with a wide range of lifestyle offers?

A suitable quality policy must be developed for every company concept. Whatever task is chosen: The quality policy is a statement that you want to tackle this task directly and how you will do it.

6.2 Confusion with mission statement

see to "Mission statement" VA 1.1.04. Hospitals are repeatedly advised to begin the development of a QM system by formulating a mission statement. However, this idea does not originate from modern quality management. The idea of the mission statement as a tool for organisational development was taken up in American companies after the Second World War in order to provide employees with community-building goals and values in line with the programmes of the political parties. Simple guiding principles were favoured, usually ten in number, analogous to the Ten Commandments. The guiding principles were intended to serve as an orientation aid to orientate thinking and actions towards clear values. Mission statements are often associated with a code of behaviour that contains attitudes, manners and rules for daily interaction, including dress codes.

The goals and values of the mission statement are binding for everyone. Some organisational developers even recommend a commission - comparable to a watchdog council or the political commissioners of certain parties - to monitor compliance with the corporate values. The "quality" of a company and its individual employees is then measured by the extent to which they fulfil the values.

A clear understanding of the task certainly makes it easier for employees to work together in the hospital. People from different social backgrounds work very closely together in a hospital. How do the attitudes of employees influence their decisions? Is there agreement on important fundamental issues, especially in ethically difficult situations of life, illness and death? Do conflicts repeatedly arise in the allocation of resources and in dealing with each other? Who lacks respect, who abuses helpfulness for selfish ends? Clear ethical and moral values seem to be indispensable in order to fulfil the mission in everyday life.
However, a feared decline in values cannot be countered by enshrining supposedly higher values. Lofty values do not always create community; they also divide or marginalise to the point of sectarianism.

The mission of a hospital must not and cannot be determined by the management or staff alone. If society had lost the guiding principle for the hospital, we would not be able to replace it through our own efforts. The ethical basis for our hospitals is clear. They cannot set their own tasks like "free" entrepreneurs. Even less can the employees change the mission according to their own ideas.
Mission statements must be realistic to avoid being misused. They must recognise lines of development - and also the limits. They must take traditions into account and leave and create room for change.

Mission statements may contain the demands and expectations of our stakeholders. However, a "mission statement" is then again identical to the quality policy, which must be formulated in such a way that the statements are verifiable. It must not contain platitudes that are undisputed everywhere, such as "Humanity helps people", "People take centre stage", "We are always there for our patients", "Health is our highest goal", "Good care is our tradition", "We are committed to quality", "We want to work as a team".

Of course, every hospital can also call its quality policy a "mission statement". This must be discussed intensively and perhaps even controversially. However, those who expect enthusiastic commitments to the "values of the new mission statement" will rightly experience harsh rejection.
Quality policy is not the right place to counteract a presumed decline in values. No one can be forced to be attentive, friendly and understanding by appeals. No ethics or morals have ever been enforced by proclamations.

As everywhere, co-operation in hospitals can only work if differences of opinion are respected. We should be particularly wary of empty formulas that the guardians of new ideas fill with content at will in order to be able to use them against supposed dissenters.

This would thoroughly spoil the idea of a quality policy.

7 Responsibilities

The consultancy is to be managed by a senior consultant.

8 Applicable documents

8.1 Literature, regulations

JCI: PFR1.1, PFR 1.2, PFR 1.3, COP.1, GLD.12; QM-RL G-BA:2015 § 3; DIN EN ISO 9001:2015 and DIN EN 15224:2017: 5.1.1 b) - d), 5.2.1, 5.2.2; DIN EN ISO 9004, T2; ISO 19600 5.2; KTQ^® :5.1.1.1, 5.1.2.1, 5.1.2.3

8.2 Terms

Quality policy

An organisation's overall intentions and direction for quality as formally expressed by top management Note 1: In general, the quality policy is consistent with the overall policy of the organisation and provides the framework for setting quality objectives. Note 2: Quality management principles of this international standard can serve as the basis for establishing a quality policy. (DIN EN ISO 9000:2015)

9 Systems