Quality assurance in medicine

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The quality assurance in medicine is in Germany by the Fifth Social Code Book determined. The aim is to develop suitable measures to ensure the quality of medical services and make them more transparent. Quality assurance in medicine stands for different approaches and measures to ensure specified quality requirements. It is not an instrument for increasing quality. At best, this results from an increase in quality requirements. The Inpatient Quality Indicators (IQI) apply as a criterion .


The concept of quality assurance in medicine must be distinguished from the concept of quality management in medicine according to Section 135a, Paragraph 2, No. 2 (formerly Section 136b, Paragraph 1, No. 1) SGB V as an institution's internal quality management . To this end, the Federal Joint Committee (G-BA) issued quality management guidelines in accordance with Section 135a (2) No. 2 SGB V and in accordance with Section 92 i. V. m. Section 137 (1) number 1 SGB V. This in turn reads from 2016 cross-sectoral quality management guidelines . The two terms quality assurance and quality management are often incorrectly used synonymously or confused.

Goal setting

Quality assurance in the broader sense is the original task of every doctor / dentist and is derived indirectly from the professional code. According to this, the individual doctor / dentist is obliged to exercise his profession conscientiously according to the requirements of medical ethics and in particular according to the rules of (dental) medical art. The conscientious exercise of the profession requires the necessary professional qualifications and compliance with the recognized state of medical knowledge (cf. § 2 model professional regulations for doctors; § 2 model professional regulations for dentists). The professional regulations serve u. a. to ensure the quality of medical and dental work in the interests of the health of the population (see preamble in the model professional regulations for dentists). The civil law treatment contract between doctor and patient also results in the doctor's obligation to provide treatment in accordance with the generally recognized professional standard in place at the time of treatment in accordance with Section 630a (2) of the German Civil Code, i.e. lege artis treatment.

This was not enough for the legislature to provide for the statutory insured. Quality assurance in medicine in Germany is now primarily determined by the Fifth Book of the Social Code and the transfer of the design of these legal requirements by the Federal Joint Committee. With the law for the modernization of statutory health insurance ( GKV-Modernisierungsgesetz , GMG) on January 1, 2004, the new Federal Joint Committee was formed as a cross-sectoral body of joint self-administration. Since then, the latter has been given the task of defining the quality assurance requirements for the contract medical, contract dentist and inpatient areas. This is intended to streamline and standardize decision-making processes for quality assurance in the various sectors (inpatient, outpatient, dental) in particular (see the reasoning for the GMG on Section 137 (1) SGB V). This intention of the legislature was further developed in the further health reforms. The aim is to keep quality assurance in the supply areas (sectors) as uniform and stringent as possible. The aim is to develop suitable measures that ensure the quality of medical services and make them more transparent. Quality assurance in medicine stands for different approaches and measures to ensure specified quality requirements. It is not an instrument for increasing quality. At best, this results from an increase in quality requirements.


Quality assurance can be divided into

  • cross-sector quality assurance,
  • sector-specific quality assurance,
  • cross-institutional quality assurance.

Cross-sector quality assurance

The cross-sector quality assurance is intended to improve patient care at the outpatient / inpatient interface. The legislature has stipulated that an institute should be commissioned to develop indicators, instruments and documentation for this purpose. The Göttingen Institute for Applied Quality Promotion and Research in Health Care (AQUA Institute) was entrusted with this task, which is given the topics by the Federal Joint Committee and which prioritizes the topics.

The utility sectors are

Cross-sectoral means that at least two of the three mentioned supply sectors are affected at the same time.

Sectoral quality assurance

Sector-related quality assurance is a special case in the context of Section 136 (2) SGB V. If the quality of a treatment can only be adequately assured in a sector-related manner, then this review is nevertheless subsumed under cross-sectoral quality assurance.

Sector-specific quality assurance

In sector-specific quality assurance, only one of the three sectors is affected. To this end, the Federal Joint Committee issues a quality assessment guideline that includes the rules of procedure and a quality assessment guideline that relates to the assessment of the assigned topics. In Section 135b (2) SGB V, the criteria for the indication-related necessity and quality of the diagnostic and therapeutic services carried out, in particular complex medical-technical services, are prescribed; Minimum requirements for the quality of the structure, processes and results must also be specified. The respective national organization is responsible.

Cross-institutional quality assurance

In cross-institutional quality assurance, the quality of the treatment of an individual service provider is to be compared with that of a collective. The collective is determined in each case. For example, it can be the entirety of the corresponding service providers from a specialty, from a country, a region or a city.

Quality assurance in the hospital

Structured quality report

The structured quality report according to § 136b SGB ​​V gives a systematic overview of the services of a hospital in Germany. This overview contains data on the number of inpatients, diagnoses and procedures. Quality indicators and quality assurance measures are also queried. The report is intended to guarantee more transparency for patients and health insurance companies.

Minimum quantity regulation

According to the resolution of the Federal Joint Committee, plannable services may not be provided if their minimum quantities are unlikely to be achieved. If these services are nevertheless provided, the hospital has no claim to reimbursement from the health insurance companies.

Quality surcharges and quality discounts

By December 31, 2017, a catalog of services or service areas is to be created that is suitable for quality-related remuneration with surcharges and discounts, including quality targets and quality indicators. If the quality is found to be inadequate, the hospital is given one year to correct the deficiencies before a discount is charged. If a hospital does not remedy the deficiencies within three years, the remuneration will be excluded ( Section 5 (3a) KHEntgG).

Hygiene quality

For the first time, the Federal Joint Committee will determine suitable measures to ensure hygiene in care by December 31, 2016 and, in particular, determine indicators for assessing the quality of hygiene for cross-institutional quality assurance in hospitals.

Quality assurance for blood transfusions

Inpatient and outpatient health care facilities that use blood products for blood transfusions (e.g. hospitals, medical practices, etc.) are obliged by Section 15 of the Transfusion Act to set up a quality assurance system.

Quality assurance encompasses the entirety of the personal, organizational, technical and normative measures that are suitable to secure and improve the quality of patient care and to further develop it in accordance with the medical and scientific knowledge (Sections 135a, 136 and 137 Fifth Book of the Social Code (SGB V)).

As part of the quality assurance system, the qualifications and tasks of the responsible persons must be specified. It is a legal requirement for all institutions that use blood products to order one

Facilities with acute care must also set up a transfusion committee and hold regular transfusion committee meetings.

The individual measures are laid down in the hemotherapy guidelines published by the German Medical Association .

Quality assurance of medical laboratory examinations

According to § 9 Medical Devices Operator Ordinance (MPBetreibV), constant internal quality control and participation in round robin tests according to the guidelines of the German Medical Association (Rili-BÄK) are mandatory for medical laboratory examinations . There is a documentation and five-year archiving obligation. The responsible calibration offices are responsible for monitoring .

Institute for Quality and Transparency in Health Care (IQTIG)

The Institute for Quality Assurance and Transparency in Health Care (IQTIG) works on behalf of the Federal Joint Committee on quality assurance measures and is intended to represent the quality of care in the health system. Since 2016, it has taken over the implementation of cross-sector quality assurance from the AQUA Institute.

Quality assurance with routine data

Quality assurance with routine data (QSR) was initiated in 2002 as a joint development project by the Scientific Institute of the AOK (WIdO) , the AOK Federal Association , the HELIOS Clinics and the Research and Development Institute for Social and Health Care Saxony-Anhalt and has been in existence since further developed by WIdO in 2008. The aim was to develop and establish a low-cost quality measurement method based on routine data for Germany that is oriented towards the quality of results. The procedure is used in the AOK hospital navigator, in which the results of selected treatments are presented on the basis of possible complications or undesirable secondary events.

Quality institutions in health care

Numerous institutions and organizations in Germany deal with quality assurance and quality development in medicine and healthcare.

See also



  • Anton Scharl, Dietrich Berg: Perinatal survey - “mother” of the QS measures . Deutsches Ärzteblatt , vol. 114 February 2017, pp. 106-108.

Individual evidence

  1. (Model) professional code for doctors working in Germany (as of 2015) , Federal Medical Association. Retrieved June 5, 2016.
  2. Model professional regulations for dentists , Federal Dental Association . Retrieved June 5, 2016.
  3. bill and law justification for GMG , German Bundestag Printed Matter 15/1525 of 8 September 2003. Retrieved on 5 June 2016th
  4. Juris - § 9 Medical Devices Operator Ordinance - MPBetreibV
  5. Guideline of the German Medical Association for the quality assurance of medical laboratory examinations - Rili-BÄK
  6. Thomas Schade: All good things come in threes. The new RiliBÄK - completely revised
  7. QSR website

Web links