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(1) The Federal Joint Committee shall issue guidelines in accordance with section 92 subsection (1) sentence 2 No. 13 for contract healthcare, and for registered hospitals, and as a matter of principle uniformly for all patients, in order to determine the following in particular
1. the mandatory measures of quality assurance in accordance with section 135a subsection (2), section 115b subsection (1) sentence 3 and section 116b subsection (3) sentence 3, bearing in mind the outcomes in accordance with section 137a subsection (3), as well as the fundamental requirements made of intra-institutional quality management, and
2. criteria for the indication-related need and quality of the diagnostic and therapeutic benefits implemented, in particular time-consuming medical technology services; here, minimum requirements shall also be made as to the structure, process and outcome quality.
Where required, it shall hand down the necessary implementing rules and principles for consequences, in particular for remuneration reductions for healthcare providers not complying with their quality assurance obligations. The Association of German Private Healthcare Insurers, the German Medical Association, as well as the professional organisations of the nursing professions, shall be involved in the guidelines in accordance with section 92 subsection (1) sentence 2 No. 13; the Federal Chamber of Psychotherapists and the German Dental Association shall be involved where the exercise of the profession of psychotherapists or dentists, respectively, is affected.
(1a) In its guidelines in accordance with subsection (1), the Federal Joint Committee shall establish suitable measures to ensure hygiene in care, and shall determine – in particular for hospitals’ inter-institutional quality assurance – indicators for the assessment of the quality of hygiene. It shall adopt the stipulations in accordance with sentence 1 for the first time by 31 December 2012. In the stipulations, the Federal Joint Committee shall take account of established procedures to record, evaluate and link back nosocomial infections, antimicrobial resistance and concerning antibiotic consumption, as well as the recommendations of the commissions established at the Robert Koch Institute in accordance with section 23 subsections (1) and (2) of the Infection Protection Act (Infektions¬schutz¬gesetz).
(1b) The results that have been measured subsequent to introduction with the indicators in accordance with subsection (1a) sentence 1 and which are suitable for publication shall be depicted in the quality reports in accordance with subsection (3) No. 4. The Federal Joint Committee shall promptly include in the quality reports information that is already available to it on the state of hygiene in the hospitals, and shall make additional stipulations in accordance with subsection (3) No. 4 to improve information on hygiene.
(1c) The Federal Joint Committee shall submit suitable measures in its guidelines in accordance with subsection (1) to safeguard quality in psychiatric and psychosomatic care, and in particular shall adopt recommendations for the allocation to the in-patient facilities of the therapeutic staff necessary for the treatment, as well as for indicators to evaluate the structure, process and outcome quality for intra-institutional and cross-sectoral quality assurance in this area. When it comes to stipulations and recommendations in accordance with sentence 1 for child and youth psychiatric care, it shall take into account the particularities emerging in particular from the age-dependent requirements as to the care of children and juveniles. It shall introduce the measures and recommendations in accordance with sentence 1 by 1 January 2017 at the latest. Information on the implementation of the recommendations for the allocation of therapeutic staff and the outcomes that are suitable after the introduction with the indicators in accordance with sentence 1, and which are suitable for publication, shall be illustrated in the quality reports in accordance with subsection (3) No. 4.
(1d) In its guidelines on the fundamental requirements of intra-institutional quality management in accordance with subsection (1) No. 1, the Federal Joint Committee shall determine essential measures to improve patient safety for the first time by 26 February 2014, and shall in particular stipulate minimum standards for risk management and error-reporting systems. Information shall be provided on the implementation of risk management and error-reporting systems in hospitals in the quality reports in accordance with subsection (3) No. 4. The Federal Joint Committee shall determine as the foundation for the agreement of remuneration supplements in accordance with section 17b subsection (1) sentence 5 of the Hospital Financing Act (Krankenhausfinanzierungsgesetz) requirements of inter-institutional error-reporting systems appearing to be particularly well suited to detect and evaluate risks and sources of error in in-patient care and contribute towards the avoidance of undesirable events.
(2) The guidelines in accordance with subsection (1) shall be adopted on a cross-sectoral basis unless the quality of the provision of benefits can only be properly ensured by sectoral regulations. The provisions contained in subsections (3) and (4) shall remain unaffected thereby.
(3) The Federal Joint Committee shall also adopt resolutions for registered hospitals, as a matter of principle uniformly for all patients, on
1. proof of compliance with the further training obligations on the part of specialist physicians, psychological psychotherapists and child and youth psychotherapists which is to be provided at five-year intervals,
2. a list of plannable benefits in accordance with sections 17 and 17b of the Hospital Financing Act where the quality of the treatment outcome depends heavily on the amount of benefits provided, as well as minimum amounts for the respective benefits per doctor or per hospital, and exceptions to this rule,
3. policy on consulting second opinions prior to interventions, and
4. the content, scope and data format of a structured quality report on the part of registered hospitals which is to be published on an annual basis, in which the state of quality assurance, particularly taking into account the requirements in accordance with subsections (1) and (1a), as well as the implementation of the provisions in accordance with Nos. 1 and 2, is portrayed. The report shall also contain information on the nature and number of the benefits of the hospital, and a declaration which, regardless of third-party rights, provides information on whether the hospital adheres to the recommendations of the German Hospital Federation in accordance with section 136a sentence 2 with regard to contracts with senior doctors; if these recommendations have not been provided by 30 April 2013, or if the hospital does not comply with them, it shall state, regardless of third-party rights, for which benefits benefit-related goal agreements were concluded; the report shall be drawn up in a standardised dataset format which is suitable for illustrating all criteria. It shall be published on the Internet over and above the group of recipients stipulated in the resolution, also by the Land associations of the health insurance funds and the substitute health insurance funds.
If the minimum quantity that is necessary in accordance with sentence 1 No. 2 with regard to plannable benefits is likely to not be reached, corresponding benefits may not be provided. The Land authority which is responsible for hospital planning can determine benefits from the list in accordance with sentence 1 No. 2 with regard to which the application of sentence 2 could place at risk the safeguarding of the universal care of the population; it shall decide at the request of the hospital, with regard to these benefits, on the non-application of sentence 2. In order to increase the transparency and quality of in-patient care, the Associations of Statutory Health Insurance Physicians, as well as the health insurance funds and their associations, may also inform registered contract doctors and the insured on the basis of the quality reports in accordance with No. 4 comparatively of the quality characteristics of the hospitals, and may make recommendations. The Association of German Private Healthcare Insurers, the German Medical Association, as well as the professional organisations of the nursing professions, shall be involved in the resolutions in accordance with Nos. 1 to 4; the Federal Chamber of Psychotherapists shall be additionally involved with the resolutions in accordance with Nos. 1 and 4. The resolutions shall be directly binding on registered hospitals. They shall take priority over contracts in accordance with section 112 subsection (1) unless the latter contain supplementary provisions on quality assurance. Quality assurance contracts in accordance with section 112 subsection (1) shall continue to apply until the entry into force of guidelines in accordance with subsection (1). Additional quality requirements within the hospital planning of the Länder shall be permissible.
(4) The Federal Joint Committee shall also adopt quality criteria for the provision of fillings and dental prostheses. The Association of German Dental Technicians’ Guilds shall be involved when setting quality criteria for dental prostheses; the statements shall be borne in mind when taking the decision. The dentist shall provide a two-year warranty for fillings and care with dental prostheses. Identical and partial repeats of fillings, as well as the renewal and restoration of dental prostheses, including crowns, shall be carried out free of charge by the dentist during this period. Exceptions therefrom shall be determined by the National Association of Statutory Health Insurance Dentists and the National Association of Statutory Health Insurance Funds. Section 195 of the Civil Code (Bürgerliches Gesetzbuch) shall remain unaffected. Longer warranty periods can be agreed between the Associations of Statutory Health Insurance Dentists and the Land associations of the health insurance funds and the substitute health insurance funds, as well as in individual or group contracts between dentists and health insurance funds. The health insurance funds may grant remuneration premiums for this; members’ co-payments towards dental prostheses shall remain unaffected thereby. Dentists who grant a longer warranty period to their patients may make their patients aware thereof.
(5) The Federal Joint Committee shall resolve on the development and implementation of quality assurance, as well as on improving the transparency of the quality of out-patient and in-patient care commissions in accordance with section 137a subsection (3), to the Institute for Quality Assurance and Transparency in the Healthcare System. Section 299 shall apply where personal data are to be transmitted in this process.