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Patrick Blumentritt
Head of Consulting North,
Quality Management & Regulatory Affairs

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18.12.2020

QM system for midwives

For most midwives, quality management systems are all Greek to them. However, since mid-2019 at the latest, the legislator has been making explicit demands on midwives, which also include requirements for the quality of care.

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Freelance midwives have for some time now been obliged to meet quality requirements for midwifery services if they want to settle accounts with health insurance companies. This is stipulated in § 134a of the German Social Security Code V (SGB V). This refers to a framework agreement which is concluded by the Central Federal Association of the Health Insurance Funds (Spitzenverband Bund der Krankenkassen) with the relevant professional associations of midwives. Without this contract, midwives are not licensed as service providers.

The quality of midwifery services should include minimum requirements for the structure, process and outcome quality and lay down administrative procedures without a big fuss to demonstrate compliance with these quality requirements. The basic elements of a quality management system to be implemented should be feasible, appropriate and necessary for a sole proprietor without connection to an institution.

What does this mean for a freelance midwife? What processes and procedures does it have to follow to meet the requirements for quality midwifery assistance? Good advice is expensive! Above all, it is advisable to establish a lean but effective quality management system which the midwife can handle and work with. The effort required to maintain the QM system should be kept to a minimum. Nothing is more of a hindrance than being kept from daily work by excessive bureaucracy.

One possibility would be to establish a QM system according to the most common standard in this area, DIN EN ISO 9001. This standard requires defined management processes, core processes and support processes. The standard DIN EN 15524 is also suitable. It is specially tailored to health care facilities and mostly reflects the requirements of DIN EN ISO 9001.

In all cases it is important that the midwife has some kind of quality policy or mission statement and defines quality objectives. She is also required to question and optimise the system at regular intervals. Annual assessments or audits, for example, serve this purpose. Requirements for occupational health and safety and health protection are also contained in the standards, as are requirements for handling data relating to insured persons. More detailed requirements can be found in Appendix 3a Quality Management of the Annex to the framework agreement.

Freelance midwives are also legally obliged to provide and maintain certain information. This includes information about the midwife herself as well as information about working materials and instruments used. The midwife is obliged to document and archive information on insured persons and to document the course of care.

In the course of documenting their activities, freelance midwives are also required to develop process charts for complex tasks and situations to which they are exposed in their daily work. Continuing education and training activities for freelance midwives also represent a point in the list of requirements that should not be neglected.  

According to Annex 3b of the framework contract, a midwife must provide proof of the start of implementation of a quality management system. This evidence must be provided within six months of becoming a contracting party. This proof can be provided in a variety of ways, for example by attending a QM training course, by a certificate from the facilities in which the midwife works, by a contract with an accredited personnel certifier or by documenting the start of the inspection of an already introduced own QM system. The implementation phase is concluded either by an internal audit through a self-assessment or an additional external audit. In the case of an audit, proof of the introduction of a QM system must be provided within 24 months of the end of a six-month planning phase, and in the case of an additional external audit within 30 months.

seleon can look back on many years of experience in the planning, implementation and evaluation of various QM systems. We would be happy to introduce a QM system for you that complies with the applicable legal requirements, that is both streamlined and easy to maintain, thus providing you with real added value. Simply contact us. We will be happy to make you an offer!

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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[Inhalt: Englisch]

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