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Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1 Seminar on QM in German hospitals 08.11.2013 - Dr. Erwig Pinter Quality assurance.

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Präsentation zum Thema: "Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1 Seminar on QM in German hospitals 08.11.2013 - Dr. Erwig Pinter Quality assurance."—  Präsentation transkript:

1 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1 Seminar on QM in German hospitals Dr. Erwig Pinter Quality assurance in German hospitals QM - Implementation Oncological Centers & OnkoZert-Certification Scheme Mandatory Certifications of German Health Care Providers QM in TeachingQM in Clinical studies

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

3 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 3 1. Quality and hospitals in Germany 2. Internal quality assurance 3. Focus in different Certification Schemes 4. External quality assurance 5. Risk management 6. Quality management in clinical reality 7. Transparency and Marketing with Quality 8. Assessment of the benefits of QM 9. Literature Topics

4 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 4 1. Quality and hospitals in Germany Topics

5 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 5 Terms according to DIN EN ISO 9000:2005 Definitions  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 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 6 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 Hospitals in Germany

7 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 7 Type Service Stationary treatment Pre- and post- stationary Day Unit Outpatient treatment Admission Treatment Board Loading Connected to Stationary Types of hospital service

8 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 8 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 Segmentation of hospitals by ownership

9 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 9 Ownership segments acute hospitals 2017 acute hospitals in Germany Source: destatis, 2012

10 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH charity based hospitals 698 private hospitals 601 public 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 Ownership segments acute hospitals 2017 acute hospitals in Germany Source: destatis, 2012

11 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 11 Segmentation data acute hospitals < 100 beds beds beds > 500 beds Total number Number of hospitals Number of inpatient care 0,8 Mio.2,2 Mio.12,4 Mio.8,0 Mio.18,3 Mio.  Length of stay in days 8,88,07,67,47,8  Number of personnel Source: destatis, 2012

12 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 12 Owners segments prevention/reha hospitals 1212 facilities in Germany Source: destatis, 2012

13 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH charity based 659 private 232 public 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 Owners segments prevention/reha hospitals 1212 facilities in Germany Source: destatis, 2012

14 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 14 Segmentation data prevention/reha hospitals < 50 beds beds beds > 200 beds Total number Number of hospitals Number of inpatient care 0,8 Mio.0,19 Mio.0,6 Mio.1,05 Mio.2 Mio.  Length of stay in days 30,327,725,352525,5  Number of personnel Source: destatis, 2012

15 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 15 Key data Source: destatis, 2012 Number of German hospitals decreased by 8% between 2000 und 2011

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

17 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Internal quality assurance Topics

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

19 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 19  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 Organisations developing quality assurance

20 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 20 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 Legal framework

21 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 21 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 Legal framework

22 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 22 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 Common Federal Council G-BA (Federal Joint Committee) Health Insurance Funds Medical Care Medical Profess- ions Dental Surgeon Hospitals

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

24 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 24 Federal Joint Committee (G-BA) requirements for the internal QM-System in a hospital Internal QM Structure Governing council or Steering committee QM-officer for the executive management 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 Other requirements Effectivity and efficiency Cost-Benefit relation

25 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 25 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 AWMF Guidelines

26 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 26 AWMF:  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 Clinical relevance of the AWMF Guidelines

27 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 27 AWMF:  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) Classifications of AWMF guidelines

28 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 28 5 stages in the life of a guideline (AWMF) Evaluation and Planning the Updating Implementation Editorial process and Publishing Development of a guideline Planning and organisation Development process of AWMF-guidelines

29 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 29 ISOKTQJCI USAOnkoZert 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 Certification of the entire hospital, 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 General and special Certification Schemes

30 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Yearly conformity audits 6. Issuance of the certificate for 3 years 5. Audit stage 2 4. Audit stage 1 3. Certifying organisation defines audit team 2. Formal pre-check of the certification application 1. Select a certifying organisation ISO-Certification

31 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 31 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 Certification status in acute hospitals

32 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 32 Source: DKA, 2012 OwnerCertifiedNon- certified Charity Public Private Hospitals  Number of non-certified acute hospitals is still predominant  Highest portion of certified acute hospitals is in the charity based owner sector Certification status in acute hospitals

33 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 33 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 Market Share of Certification Schemes in German acute hospitals Source: DKA, 2012

34 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 34 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 Schemes in owner sectors Source: DKA, 2012 Certification distribution

35 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 35 These three hospitals are certified in Germany according to JCI:  Central Military Hospital Koblenz  Clinics of Red Cross Berlin  Communal Central Hospital Chemnitz JCI-Certifications

36 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 36 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 Standards

37 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 37 ISOKTQ 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 Critics to General Certifications Schemes

38 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 38 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.) Assessment after 20 years QM experience

39 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 39 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 The prospective Standard in Europe

40 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 40 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) Associations emphasizing and influencing QM

41 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 41 CertificateAssociation Number of certified facilities OnkoZertGerman Cancer Association Organ-Cancer Centers: 860 Oncological Centers: 57 Comprehensive Cancer Centers (CCC) 3 DGHO German Association of Hematology and Oncology Oncological Centers: 40 Competence Centers: 3 Study Centers: 6 Quality Seal DDG German Association of Diabetology For Clinics: Basic recognition: 248 Diabetologicum: 48 Podological specialist for treatment of diabetic feet: 79 Special Certification schemes of Associations

42 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 42 CertificateAssociation Number of certified facilities Quality seal for children hospitals Association of children hospitals and children clinics in Germany Clinics for Children and adolescent: 280 Centers for vessel diseases German Asociation of angiology, German Association of vessel surgery, German Association of radiology Vessel Centers: 66 Nephrological focus clinic German Association of nephrology Focus Clinics: 22 Special Certification schemes of Associations

43 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Focusing different Certification Schemes Topics

44 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 44 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 DIN EN ISO 9001:2008

45 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 45 Categories 1. Patient-orientation in Patient Care 2. Ensuring employees-orientation 3. Safety in Hospital 4. Information 5. Hospital management 6. Quality management KTQ – catalogue version 5.0

46 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 46 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 JCI – catalogue 4. revision I

47 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 47 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 JCI – catalogue 4. revision II

48 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Structure and processes (e.g tumour boards) 2. Organ-specific diagnostics 3. Radiology 4. Nuclear medicine 5. Surgical Oncology 6. Chemotherapy/Internal Oncology 7. Radiooncology 8. Pathology 9. Palliative Care und Hospice service 10. Tumour documentation/Outcome quality OnkoZert - Survey

49 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 49 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 Trauma Network - Requirements

50 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH External quality assurance Topics

51 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 51 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 External quality assurance

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

53 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 53  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 Results of the external quality assurance 2012 Quelle: AQUA Institut, 2013

54 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 54  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 reports of hospitals Quality Report

55 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Risk management Topics

56 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 56  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 Risk management

57 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 57 Risk management as part of quality management  Avoiding to do the same work twice  Efficient resource management  Harmonised documentation  Transparency of structures  Legal security Risk management RM QM

58 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 58 Risk management process becomes more and more important for hospitals in Germany  Patients rights law  DIN EN 15224:2012  Alliance Action for patient safety Risk management 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 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 59 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 Risk management

60 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 60 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 Risk management Survey of the Alliance Action, 2012

61 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 61 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 CIRS

62 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 62 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 CIRS Survey of the Alliance Action, 2012

63 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 63 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 Risk management

64 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 64 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” Patients rights law

65 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Quality management in clinical reality Topics

66 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 66 Level of competence Acute hospital segmentation in treatment/size Maximal spectrum hospitals Hopitals with main focuses Regular and basic services Differentiation and scope of service spectrum 1000 beds beds beds

67 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 67 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 QM implementation approaches differ

68 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 68 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 in regular and basic hospitals QM

69 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 69  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 QM in main focus hospitals QMB Central QM

70 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 70  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). QM in maximal spectrum hospitals Top management and central QM QMB Central QM QMB Central QM QMB Central QM

71 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Transparency and Marketing with Quality Topics

72 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 72 Hospital navigator4QD-Quality clinics Top-ranking doctors list Focus Ranking list of hospitals or of doctors in weekly magazin Focus Online search for the best suitable hospital on basis of parameters important for patients provided by biggest health insurer Online portal with open comparative ranking of participating primarily private hospitals Transparency and Marketing with Quality

73 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 73 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 Transparency and Marketing with Quality

74 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 74 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 Transparency and Marketing with Quality

75 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 75 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 Transparency and Marketing with Quality

76 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 76 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 Transparency and Marketing with Quality

77 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 77 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 Transparency and Marketing with Quality

78 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Assessment of the benefits of QM Topics

79 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 79 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 QM postgraduate education as success factor

80 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 80  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) 1. Application  of the implemented methods and elaborated standards is not successful 2. Monitoring, measuring and act  deficiencies in the independent evaluation of the results of QM  deficiencies in act to improve timely the non-conformities Areas for improvement Plan Do Check Act 2 1

81 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 81 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 Areas for improvement M. Geraedts et al. 2010

82 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 82 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 Effectivity of QM S. Pilz et al. 2013

83 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 83 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 Effectivity of QM S. Pilz et al. 2013

84 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 84 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 Effectivity of QM Significance of the cooperation between QM and executives S. Pilz et al successful less successful

85 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 85  Different possible roles of QM in a hospital: Effectivity of QM Sommerhoff 2012 leading changing subordinate preservative Orientation of QM Position of QM Organisational development Project reserve Security Force Control station - Quality Control - Repair - Management system-administrator - Quality Control - Moderator in conflicts - Management system-designer - Change manager - Internal Consultant - Project manager - Project service

86 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 86 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. Mandatorily required QM

87 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH Literature Topics

88 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 88  Homepage Bundesministerium für Gesundheit:  Homepage Deutsche Krankenhausgesellschaft:  Homepage G-BA:  Homepage AWMF:  Homepage BÄK:  Homepage Aktionsbündnis Patientensicherheit:  Homepage GQMG:  Homepage AQUA Institut: Literature


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