1.1.07 Recognised rules

1 Purpose and objective

The operation and services of a hospital are subject to requirements that are binding in a given context. They are laid down in a large number of laws and regulations (legal requirements in accordance with 3.6.6 ISO 9000:2015) or directives and guidelines as well as professional rules (official requirements in accordance with 3.6.7 ISO 9000:2015). The organisation can subject itself to self-defined requirements, which are then binding (mandatory) in the same sense.

The management determines the group of interested parties and a catalogue of their requirements and expectations. These include legal and regulatory requirements, professional standards, requirements of the funding organisations, special requirements from the medical and specialist professional regulations and professional requirements of the occupational groups. The requirements should be formally recognised.

As the hospital is part of the "regulated sector", the list contains at least the requirements that apply even without formal recognition, such as the Hospital Act, Federal Nursing Care Rate Ordinance, Infection Protection Act, Hospital Hygiene Directive, Quality Assurance Guidelines in the Laboratory, X-ray Ordinance, etc. This also includes the professional regulations and the training and further training guidelines. Other fundamental documents should be listed here, such as the Declaration of Helsinki and the World Medical Association, a patient charter or other ethical codes.

The management of the hospital draws up a catalogue of documents containing requirements for the operation and services of the hospital. The management recognises the requirements from the aforementioned documents, which may be of importance for the provision of services and the assurance of their quality in the clinics, departments and areas, as binding obligations in the sense of the compliance obligation (authoritative binding obligations in accordance with DIN ISO 19600:2014).

The management makes no claim to the completeness of the catalogue, i.e. it cannot be concluded from the absence of an entry that the missing regulation does not apply, is not recognised or is not implemented in the hospital. It is also possible that some documents are not relevant to the organisation.

The "Catalogue of Recognised Requirements and Expectations" is to be updated on an ongoing basis.

2 Scope of application

The catalogue includes documents that specifically affect the general management responsibility for healthcare, the practice of medicine, nursing, education, training, continuing education, safety (hygiene, equipment, buildings, etc.) and, if applicable, clinical research.

The binding nature of the requirements is derived from the self-commitment of the management, which results from recognising the documents. The question of the extent to which fulfilment can be enforced by coercion is deferred. For example, contracts with health insurance funds, other types of cost bearers, agreements with the staff council, recommendations from professional associations, etc. can also be included in the catalogue.

The entries do not apply equally to all departments of the hospital. The addressees should be named for all documents and included in the register cards of the documents.

3 Description

The list is to be continuously expanded and updated in the event of changes to individual documents. The responsibility for ensuring that the legal regulations are complied with lies - as before - with the department heads. The catalogue of recognised rules includes documents whose validity is recognised for xy Hospital. The catalogue is an excerpt. The catalogue is updated on an ongoing basis. The version with the highest consecutive number is always valid. The preceding code is an internal coding for finding the text in the EDP system.

To the directory

4 Responsibility, qualification

The coding refers to the code of the full text in a database that is continuously maintained. Under this code, most full texts can be requested from <insert the organisation that maintains the system here, e.g. QM coordinator. The full texts are accessible via the hospital information system. QM Coordination or the registry, for example, is responsible for maintaining the "Recognised rules". All laws, standards and guidelines that are relevant to the xy hospital and its departments should be listed. The registry or QM coordination therefore requests all parties involved to provide relevant documents. The registry can only update the database reliably if the relevant information is provided.

5 Documentation

The publishers are listed in the sections. For the publishers, a link to their website is provided. Where available, a link is provided to the page on which the documents are listed. For copyright reasons and to ensure updating, documents are only kept on the GHP server in individual cases.

6 Notes and comments

All employees are asked to contribute to the updating of the "Recognised Rules" and to draw attention to any missing documents.

7 Applicable documents

7.1 Literature

DIN EN ISO 9001:2015 and DIN EN 15224:2017 4.2; 5.1.2 a); 8.2.2 a); 8.2.3 d); 8.3.3 c); 8.4.2 c); 8.5.5 a); 0.1.7 g); 1.1; 8.2.1 g); 8.7.2; DIN ISO 19600:2014 4.5.1, 4.5.2, 7.5.1 - 7.5.3; DIN ISO 37301:2021 JCI COP.1FMS.01.00; QM-RL:2015

7.2 Terms

Attachments

Proposal for a VA "Recognised rules"

Recognised rules