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Seminar on QM in German hospitals

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1 Seminar on QM in German hospitals
Quality assurance in German hospitals QM - Implementation Mandatory Certifications of German Health Care Providers Oncological Centers & OnkoZert-Certification Scheme QM in Teaching QM in Clinical studies Dr. Erwig Pinter

2 Quality assurance in German hospitals
Dr. Erwig Pinter, QKB Qualität im Krankenhaus Beratungsgesellschaft mbH

3 Topics Quality and hospitals in Germany Internal quality assurance
Focus in different Certification Schemes External quality assurance Risk management Quality management in clinical reality Transparency and Marketing with Quality Assessment of the benefits of QM Literature

4 1. Quality and hospitals in Germany
Topics 1. Quality and hospitals in Germany

5 Definitions Terms according to DIN EN ISO 9000:2005
Quality: “degree to which a set of inherent char­acteristics fulfils requirements” Quality management (QM): “coordinated activities to direct and con­trol an organization with regard to quality” Quality management system (QM-System): “management system to direct and control an organization with regard to quality”

6 Hospitals in Germany Definition according to § 2 no. 1 Hospital Law:
Medical and nursing assistance Diagnosing, healing or relieving of diseases, suffering or disfunctions or obstetrics Board and Loading of persons

7 Types of hospital service
Stationary treatment Pre- and post- stationary Day Unit Outpatient treatment Admission Treatment Board Loading Connected to Stationary

8 Segmentation of hospitals by ownership
Public Hospitals: Owner is Federal Republic or a Federal State, Communal Authority or a Social insurance Charity based Hospitals: Owners are Churches, Social associations foundations, Associations Private Hospitals: Owners are private companies, organisations or persons

9 Ownership segments acute hospitals
2017 acute hospitals in Germany Source: destatis, 2012

10 Ownership segments acute hospitals
2017 acute hospitals in Germany 601 public hospitals 698 private hospitals 718 charity based hospitals 0,17 Mio. beds 6,41 Mio. cases/year 0,24 Mio. beds 9,1 Mio. cases/year 0,09 Mio. beds 3 Mio. cases/year Source: destatis, 2012

11 Segmentation data acute hospitals
< 100 beds beds beds > 500 beds Total number Number of hospitals 696 443 624 254 2017 Number of inpatient care 0,8 Mio. 2,2 Mio. 12,4 Mio. 8,0 Mio. 18,3 Mio.  Length of stay in days 8,8 8,0 7,6 7,4 7,8  Number of personnel 51 199 466 1666 - Source: destatis, 2012

12 Owners segments prevention/reha hospitals
1212 facilities in Germany Source: destatis, 2012

13 Owners segments prevention/reha hospitals
1212 facilities in Germany 321 charity based 232 public 659 private 0,07 Mio. beds 0,3 Mio. cases/year 0,03 Mio. beds 0,4 Mio. cases/year 0,11 Mio. beds 1,3 Mio. cases/year Source: destatis, 2012

14 Segmentation data prevention/reha hospitals
< 50 beds 50-99 beds beds > 200 beds Total number Number of hospitals 286 261 355 310 1212 Number of inpatient care 0,8 Mio. 0,19 Mio. 0,6 Mio. 1,05 Mio. 2 Mio.  Length of stay in days 30,3 27,7 25,35 25 25,5  Number of personnel 19 39 82 148 - Source: destatis, 2012

15 Key data Number of German hospitals decreased by 8% between 2000 und 2011 Source: destatis, 2012

16 Key data acute hospitals
Population in Germany: 82 Mio. 2017 acute hospitals in total 18,3 Mio. stationary patients 83 Mrd. € turnover cost/year = 3,6 Bio. Rubel (3,2 % gross national product) 6 Mio. emergency cases 18 Mio. outpatients 160 tsd. Physicians 700 tsd. Nurses, Function service, Medical engineers 80 tsd. Administration 200 tsd. Others (technicians etc.) 1,1 Mio. professionals Source: DKG 2011 and destatis, 2012

17 2. Internal quality assurance
Topics 2. Internal quality assurance

18 Development of QM in Germany
2013: - Mandatory certification of rehabilitation hospitals, - quality assurance report with 289 quality indicators, - patients rights law 1975: Quality Control: Munich perinatal study 1989: external quality assurance : Demonstration project QM 2004: G-BA 2000: Internal QM, federal governing board for quality assurance 2005: Quality assurance report, Alliance Action for patient safety  Increasing requirements for proving and for transparency

19 Organisations developing quality assurance
National Association of Statutory Health Insurance Funds National Association of Statutory Health Insurance Physicians National Association of Statutory Health Insurance Dentists German Hospital Federation Federal Medical Chamber Council of Nursing

20 Legal framework Social Code Five (SGB V)
§ 70 SGB V: Quality, Humanity and Economic Efficiency Health care for the Insured according to the recognized medical evidence Sufficient, advisable and not exceeding the extend of necessity According to the professionally required quality

21 Legal framework Social Code Five (SGB V)
Since the year 2000 steadily more specific and demanding: § 135a SGB V: Requirements for quality assurance Implementation and further development of an internal QM Participation in measures for external quality assurance § 137 SGB V: Regulations and decisions for QM Federal Joint Committee (G-BA) formulates basic requirements for an internal QM and defines quality indicators for the legally requested quality report

22 Common Federal Council
Federal Joint Committee (G-BA) Highest regulating committee of the self governing authority of the health care partners Regulatory competency Defines services of health professions to be paid by the health insurance funds QM in the medical care Regulations in quality management: internal QM, external quality assurance (=quality control), quality report G-BA (Federal Joint Committee) Medical Profess-ions Medical Care Dental Surgeon Hospitals Health Insurance Funds

23 Requirements for an internal QM in Germany
Mandatory elements of the internal QM according to the Federal Joint Committee (G-BA) Efficiency Patient orientation Process orientation Elements of the internal QM Target-orientation and flexibility Responsibility and leadership Continuous improvement Preventing and handling of failures Employee-orientation, cooperation and participation

24 Internal QM Federal Joint Committee (G-BA) requirements for the internal QM-System in a hospital Processes QM as part of the facility policy Patient orientation Responsibility of the hospital directorate Key processes, Evidence based Medicine with clinical pathways, guidelines, standards Structure Governing council or Steering committee QM-officer for the executive management Other requirements Effectivity and efficiency Cost-Benefit relation

25 AWMF Guidelines Working Group of the Scientific Medical Associations (AWMF): Systematically developed (Evidence based medicine) Describe the Current state of the art and medical science Ascertain the decision making procedures of doctors and patients in respect to an adequate medical diagnostic and treatment standard for specific diseases or health problems Clear recommendations to act based on assessements of the scientific value and usability of study results

26 Clinical relevance of the AWMF Guidelines
Guidelines are corridors for the medical decisions and actions Deviations are possible in certain cases, but reasons have to be stated The workflow according to the scientific guidelines of the AWMF has to be adapted to the individual applicability in an individual situation according to the parameters indication consultation, preferences participation in decision making

27 Classifications of AWMF guidelines
S1: Recommendations of scientific expert groups S2: Guidelines based on evidence (S2e) or consensus of a discipline representing committee (S2k) S3: Guidelines based on evidence as well as on the consensus of a discipline representing committee Remark: In Germany it is important for the doctors liability to obey in detail at least the S-3 guidelines (and a must to get some certifications like OnkoZert)

28 Development process of AWMF-guidelines
5 stages in the life of a guideline (AWMF) Planning and organisation Development of a guideline Editorial process and Publishing Implementation Evaluation and Planning the Updating

29 General and special Certification Schemes
ISO KTQ JCI USA OnkoZert Basics Requirements DIN EN ISO 9001 Question- Catalogue with 6 categories JCI- accreditation standards in 14 chapters OnkoZert Questionnaire with 10 chapters German Cancer Soc. Certifi-cation Certification audit Self assessment and conformity assessment Self assessment, accreditation-survey Certification audit by team of general QM-auditor and oncological expert Special characteristics Structured QM, process orientation, certification of organisational parts of the hospital possible, internationally recognized, yearly control audit, internal audits Certification of the entire hospital, specific German certification model for health sector from USA, internationally recognised Oncological centers: comprehensive cancer centers, cancer organ center, cancer entities, cancer based items, certified general internal QM-System as pre-requirement

30 ISO-Certification 1. Select a certifying organisation
2. Formal pre-check of the certification application 3. Certifying organisation defines audit team 4. Audit stage 1 5. Audit stage 2 6. Issuance of the certificate for 3 years 7. Yearly conformity audits

31 Certification status in acute hospitals
Problems in status assessment: no publicly available source about precise certification numbers since certification in acute hopitals is voluntarily Each certified hospital promotes its own certification Only active KTQ certifications are listed publicly ISO certifications are not released from the certification organisations Private data sources about hospitals differ in definitions from the Federal Authority of Statistics Result: We could evaluate for you the current certification situation only on a reference basis of about ¾ of the 2017 acute hospitals, namely in 1576, but we can offer at least an overall view of conclusions

32 Certification status in acute hospitals
Number of non-certified acute hospitals is still predominant Highest portion of certified acute hospitals is in the charity based owner sector Owner Certified Non-certified Charity 285 345 Public 217 315 Private 127 287 Hospitals 629 947 Source: DKA, 2012

33 Market share of Certification Schemes
Acute hospitals: about 40 % of the acute hospitals in Germany are certified in General Certification Schemes (status 2012) Many hospitals are additionally certified in specific disease certification Schemes Rehabilitation hospitals: Each rehabilitation hospital is mandatorily required to show its valid certificate Market Share of Certification Schemes in German acute hospitals Source: DKA, 2012

34 Certification Schemes in owner sectors
Distribution of KTQ and ISO Certifications in owner-sectors: ISO certification: more frequently at private acute hospital owners KTQ certification: more frequently in charity based and public acute hospitals Certification distribution Source: DKA, 2012

35 JCI-Certifications These three hospitals are certified in Germany according to JCI: Central Military Hospital Koblenz Clinics of Red Cross Berlin Communal Central Hospital Chemnitz

36 Standards ISO QM Standards:
DIN EN ISO 9000:2005, Quality management systems- Fundamentals and vocabulary DIN EN ISO 9001:2008, Quality management systems, Requirements DIN EN 15224:2012, Health care services - Quality management system

37 Critics to General Certifications Schemes
ISO KTQ Basics Not specific for Health Care. Origins from Industry 3 year periods between conformity assessements Benefit Valuable structured approach but not all ISO elements meet the special needs of indiviual patient Self-assessment is big workload (1/2 year) in the valuable overall evaluation. Implementation of the possible improvements however is separate act Special characteristics Some doctors see much formalism not really improving outcome but hindering patient work If executives are not convinced by QM and their necessary daily support goes to a minimum: the hospital freezes in QM between the 3 yearly self-assessements -> No further organization developement

38 Assessment after 20 years QM experience
Preferred is structured QM approach of ISO type but only with special touch to meet the health sectors needs: Development in the health-care sector in understandable language of the health care professionals Focus on patient orientation Evidence based medicine Risk-management Prevention of defects and non-conformities Usable for all health-care organisations For small and very complex organisations with all necessary aspects (patient care, medical competence, clinical pathways etc.)

39 The prospective Standard in Europe
DIN EN 15224:2012 Defines ISO 9001 for the health-care sector Specifically designed for all healthcare services Requirements to the QM-system Will become the main certification standard Language of the health-care sector Emphasizes the process orientation and risk-management Three standards: clinical process, process of science and process of teaching Combined certification according to DIN EN ISO 9001 is possible

40 Associations emphasizing and influencing QM
Examples for associations of medical doctors German Association of hematology and oncology (DGHO) German diabetes Association (DDG) Association of children hospitals and children departments in Germany e.V. (GKindD e.V.) German Association of orthopedics and traumatology (DGOU) German association of angiology (DGA) Example for other associations German Cancer Association (DKG)

41 Special Certification schemes of Associations
Certificate Association Number of certified facilities OnkoZert German Cancer Association Organ-Cancer Centers: 860 Oncological Centers: Comprehensive Cancer Centers (CCC) DGHO German Association of Hematology and Oncology Oncological Centers: Competence Centers: Study Centers: Quality Seal DDG German Association of Diabetology For Clinics: Basic recognition: Diabetologicum: Podological specialist for treatment of diabetic feet: 79

42 Special Certification schemes of Associations
Certificate Association Number of certified facilities Quality seal for children hospitals Association of children hospitals and children clinics in Germany Clinics for Children and adolescent: Centers for vessel diseases German Asociation of angiology, German Association of vessel surgery, German Association of radiology Vessel Centers: Nephrological focus clinic German Association of nephrology Focus Clinics:

43 3. Focusing different Certification Schemes
Topics 3. Focusing different Certification Schemes

44 DIN EN ISO 9001:2008 4. Quality management System
Main chapters of DIN EN ISO 9001:2008: 4. Quality management System 5. Management Responsibility 6. Resource Management 7. Product realization 7.5 Production and Service provision (Patient care) 8. Measurement, analysis and improvement

45 KTQ – catalogue version 5.0
Categories Patient-orientation in Patient Care Ensuring employees-orientation Safety in Hospital Information Hospital management Quality management

46 JCI – catalogue 4. revision I
Patient oriented Standards International Targets for Patient safety Access to and continuity of treatment Patient and family rights Assessment of Patients Treatment of Patients Anesthesiology und surgical treatment Management and application of medicines Training of patients and of their relatives

47 JCI – catalogue 4. revision II
Organisational oriented Standards Quality improvement and Patient safety Prevention and Control of infections Control, Leadership and Management Facility Management and security Qualifications of employees and further education Communication and Information management

48 OnkoZert - Survey Structure and processes (e.g tumour boards)
Organ-specific diagnostics Radiology Nuclear medicine Surgical Oncology Chemotherapy/Internal Oncology Radiooncology Pathology Palliative Care und Hospice service Tumour documentation/Outcome quality

49 Trauma Network - Requirements
Compliance with requirements defined in checklists: Profile checklist for facilities for the Basic Treatment of severely injured persons Checklist for a Regional Trauma Center Profile Checklist for a Supraregional Trauma Center Requirements: Personnel requirements Facility and equipment requirements Measures for Quality Assurance

50 4. External quality assurance
Topics 4. External quality assurance

51 External quality assurance
Measures for external quality assurance according to the Federal Joint Committee’s requirements: Goal: improvement of the quality and comparability of health care services German-specific Documentation and transmitting of data to the evaluating institute in regard to defined quality indicators in 30 chapters e.g. obstetrics, transplantation of cardiac pacemaker Recording and analyzing data across all hospitals in Germany Some quality indicators are also part of the quality report

52 External quality assurance
1. Patient care and documentation 2. Transmitting the data to the AQUA Institute and regional authority for quality assurance 3. The regional authority and the AQUA Institute analyze the data 4. Inform hospitals about results of the analysis 5. “Structured dialog” in significant deviations from normal 6. Objective agreement on quality improving measures

53 Results of the external quality assurance 2012
1658 hospitals participated 465 quality indicators of 30 chapters 4 Mio. data sets to analyze Results: In total, the quality of health care in Germany is on a high level But specific potentials for improvement identified: E.g. Current documentation in the field of liver transplantation has to be strengthened with more parameters Quelle: AQUA Institut, 2013

54 Quality reports of hospitals
Legal obligation for hospitals to publish yearly a quality report Content, range and data format are defined by the Federal Joint Committee (G-BA) Part A: information about structure and health care services of the hospital Part B: information about structure and health care services of specialty departments of the hospital Information about quality assurance Quality Report

55 Topics 5. Risk management

56 Risk management Risk “the combination of the probability of an event and its consequences” Risk-management “coordinated activities to direct and con­trol an organization with regard to quality” Clinical risk “negative effects on the patient outcome according to quality requirements in health care“ E.g. wrong treatment, complications

57 Risk management Risk management as part of quality management
Avoiding to do the same work twice Efficient resource management Harmonised documentation Transparency of structures Legal security QM RM

58 Risk management Risk management process becomes more and more important for hospitals in Germany Patients rights law DIN EN 15224:2012 Alliance Action for patient safety 1. Establishing the context of use 6. Monitoring and review 2. Risk identification 5. Risk measures 4. Risk evaluation 3. Risk analysis DIN ISO 31000:2011

59 Risk management Partners of the Alliance action for patient safety
Federal Joint Committee German Federation of Hospitals Health Insurers Charité Berlin Private Hospital Chain Projects: Action on Patient Safety Action Clean hands! (Hygienic project) Hospital network CIRS Germany Time out procedures

60 Risk management Survey of the Alliance Action for patient safety
Deals with the status of implementing a clinical risk management system in Germany Results: 484 hospitals participated 27% implemented a risk management system 31% have a strategy for implementing a system Survey of the Alliance Action, 2012

61 CIRS Critical incident reporting system (CIRS)
Goal: prevention by collecting information about critical incidents, learning from failures Factors for success: No sanctions Voluntary, anonymous, trust Analysis of incidents by experts System-oriented Mainly based on a program from a medical liability insurer

62 CIRS Realisation of CIRS in German hospitals
Survey of the Alliance Action for patient safety 35% have a systematic CIRS Main risk factors identified yet: Interaction between departments pharmacotherapy Infections Hygiene Survey of the Alliance Action, 2012

63 Risk management Learning from the aviation CIRS-systems Checklists
Certification procedures for medical and nursing personnel Training Centers Simulator Training Psychological behavior in stress situations Become sensitive to systematic non-conformities Focus on preventive action

64 Patients rights law Goal: Patient safety and empowerment of patients
Codification of court decisions in more than the last 30 years medical liability claims Asserts legally the status of the continuously extended patients rights and the defined good medical practice in Germany by Courts Some new requirements: Doctor has to proof information consent (now it is doctors burden to proof before court. Before it was patients burden) Requirements regarding documentation: General rule: “What is not documented did not happen”

65 6. Quality management in clinical reality
Topics 6. Quality management in clinical reality

66 Acute hospital segmentation in treatment/size
Level of competence Differentiation and scope of service spectrum Maximal spectrum hospitals Hopitals with main focuses Regular and basic services 1000 beds + beds beds

67 QM implementation approaches differ
QM-approaches differ due to hospital size and service: We experienced during the 20 years QM realisation in respect to type and extent of QM realisation: Dominating factors in initiatialization and realisation of QM Basic Services: Individual executive experiences Main focus Services: Recommendations of associations Maximal Service: Legal requirements factor

68 QM in regular and basic hospitals
Short way communications and decisions Two possible ways: QM is responsibility of some individual persons additionally to and together with their actual work or Special appointed member of management with responibility for Qualitätsmanagement and e.g. risk- management Important: Priority setting is a must in different QM-projects QM

69 QM in main focus hospitals
Central QM reports to executive management with some special employees for QM Appointed QM persons (QMB=ISO 5.5.2) in individual clinics with tasks and responsibilities more specifically differentiated QMB Central QM

70 QM in maximal spectrum hospitals
Central QM in the top management of the Holding Local QM in the different sites Specialists for the different QM-sectors in the central QM Central QM responsible for Public relations and marketing with QM-topics and the further strategic developing of QM as well as of their organisation (think tank). Top management and central QM QMB Central QM

71 7. Transparency and Marketing with Quality
Topics 7. Transparency and Marketing with Quality

72 Transparency and Marketing with Quality
4QD-Quality clinics Hospital navigator Online portal with open comparative ranking of participating primarily private hospitals Online search for the best suitable hospital on basis of parameters important for patients provided by biggest health insurer Top-ranking doctors list Focus Ranking list of hospitals or of doctors in weekly magazin Focus

73 Transparency and Marketing with Quality
4QD-Quality clinics Initiative of private hospital chains , e.g. Sana, Rhön, Asklepios Voluntary partcipation of hospitals Mutual audits of the participating clinics Quality indicators: 340 indicators regarding Outcome quality 21 indikators regarding patient safety 10 each regarding patient and practitioner satisfaction

74 Transparency and Marketing with Quality
4QD-Quality clinics Search for the suitable hospital according to the speciality clinics, indications, treatment possibilities and location Online search with certain parameters or with the body picture Patient gets informations about: Clinic details Quality parameters Quality Certificate Treatment spectrum Main focuses Equipment/Service

75 Transparency and Marketing with Quality
Hospital navigator Initiative of the statutory health insurance (AOK) Informations are based on the Legally requested Quality reports Voluntary informations of the hospitals Results of patient satisfaction surveys of the legal health insurers (Patient Experience Questionaire) Anonymised routine data from the datapools of the health insurers No verification procedure regarding the voluntary informations of the hospitals and the Quality reports

76 Transparency and Marketing with Quality
Hospital navigator Comparison of at least two hospitals in: General informations Recommendations by patients Main focuses of the hospital Personnel Quality Assurance with routine data Legally required para- meters of the QA Patient satisfaction

77 Transparency and Marketing with Quality
Top-ranking doctors list Focus The weekly magazin “Focus” publishes periodically ranking lists of specialised doctors and of hospitals based on quality parameters Quality Indicators: Recommendations of doctor collegues Recommendations of associations of patients Selfassessements of the doctors publications Written and phone interviews

78 8. Assessment of the benefits of QM
Topics 8. Assessment of the benefits of QM

79 QM postgraduate education as success factor
Focus in personnel training in Germany very important Mandatory further education of doctors has to be proven all five years (via collection of certification points per event) Additional special health personal trainings in QM, teambuilding, teamwork and communication Most important in practical terms (BÄK/Bundesärztekammer): QM-qualification by the Federal Medical Association “Curriculum of medical quality management” 200 hours in three parts in one year with examination Target groups: Medical chief executives, senior physicians and Consultants

80 Areas for improvement QM has to be implemented and is to be applied in the entire hospital (S. Pilz et al. 2013) Deficiences in the implementation (N. Kasper, 2011) Application  of the implemented methods and elaborated standards is not successful Monitoring, measuring and act  deficiencies in the independent evaluation of the results of QM  deficiencies in act to improve timely the non-conformities 1 Plan Act Do Check 2

81 Areas for improvement Surveys on behalf of the Federal Joint Committee about the perception of the users about the Quality Reports Patients and doctors underutilize the Quality Reports of the clinics in the clinic selection Patients in majority don‘t even know the Quality Reports Perception of the hospitals Quality Reports do merely adequate reflect the real spectrum and quality of the services of a clinic Quality Reports have to be improved in the way of presentation, detailedness, comprehensibility for lay people, freedom of too narrow legal arrangement M. Geraedts et al. 2010

82 Effectivity of QM Study of the Society of Quality management in Health Care: The role of QM personnel in hospitals Anonymous Online-Survey of QM-employees in health care 248 participants in Germany: different owners and sizes of the facilities 77% of the participating facilites had been certified S. Pilz et al. 2013

83 Effectivity of QM Results
dynamic, developmental QM contributes effectively by Structuring, establishing tranparency of and optimizing the internal workflow Minimizing costs and risks Increasing patient safety Assisting the top management S. Pilz et al. 2013

84 Effectivity of QM Results
The crucial success factor: Close cooperation between QM and Top management Top management of successful facilites typically requires and accepts the support by QM Significance of the cooperation between QM and executives less successful successful S. Pilz et al. 2013

85 Effectivity of QM leading Organisational development Control station
Different possible roles of QM in a hospital: - Quality Control - Moderator in conflicts - Management system-designer leading - Change manager - Internal Consultant Position of QM Organisational development Control station preservative changing Orientation of QM Security Force Project reserve - Quality Control - Repair - Management system-administrator - Project manager - Project service subordinate Sommerhoff 2012

86 Mandatorily required QM
Certified QM in health sector is becoming more and more mandatorily required by law: QM as safety factor in economically stringent situations Convincing evidence for benfits by QM in outcome and processes based on our practical experience Medical laboratories have to prove specified capabilities Certifications required: Rehabilitation hospitals Dentists Mandatorily QM implementation: QM has to be implemented mandatorily by law in each health service, e.g. practitioners, emergency medical service, psychiatry etc.

87 Topics 9. Literature

88 Literature Homepage Bundesministerium für Gesundheit: Homepage Deutsche Krankenhausgesellschaft: Homepage G-BA: Homepage AWMF: Homepage BÄK: Homepage Aktionsbündnis Patientensicherheit: Homepage GQMG: Homepage AQUA Institut:

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