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Seminar on QM in German hospitals

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. 08.11.2013 - Dr . Erwig Pinter.

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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 MandatoryCertificationsof German Health Care Providers Oncological Centers &OnkoZert-CertificationScheme QM in Teaching QM in Clinical studies 08.11.2013 - Dr. ErwigPinter

  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. Topics 1. Quality and hospitals in Germany

  5. Definitions Terms accordingto 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 managementsystem (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

  8. Segmentation of hospitals by ownership Public Hospitals: • Owneris Federal Republicor a Federal State, Communal Authority or a Social insurance Charity based Hospitals: • OwnersareChurches, Social associationsfoundations, Associations Private Hospitals: • Owners are private companies, organisations or persons

  9. Ownership segmentsacutehospitals 2017 acutehospitals in Germany Source: destatis, 2012

  10. Ownership segmentsacutehospitals 2017 acutehospitals in Germany 718 charitybasedhospitals 601 publichospitals 698private 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 Source: destatis, 2012

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

  13. Owners segments prevention/reha hospitals 1212facilities in Germany 321 charitybased 232public 659private 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 dataprevention/rehahospitals 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. 18,3 Mio. stationary patients 2017 acutehospitals in total 83 Mrd. € turnover cost/year= 3,6 Bio. Rubel (3,2 % grossnational product) 18 Mio. outpatients 6 Mio. emergencycases 160 tsd. Physicians 700 tsd. Nurses, Function service, Medical engineers 1,1 Mio. professionals 80 tsd. Administration 200 tsd.Others (technicians etc.) Source: DKG 2011 and destatis, 2012

  17. 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 1997-2000: 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 StatutoryHealth 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 bepaid 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, EvidencebasedMedicinewithclinicalpathways, 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): • Systematicallydeveloped (Evidencebasedmedicine) • Describe the Currentstateof the art and medicalscience • Ascertain the decisionmakingproceduresofdoctors and patients in respectto an adequatemedicaldiagnostic and treatmentstandardforspecificdiseasesorhealthproblems • Clear recommendationstoactbased on assessementsof the scientificvalue and usabilityofstudyresults

  26. Clinical relevance of the AWMF Guidelines • AWMF: • Guidelines arecorridorsfor the medicaldecisions and actions • Deviationsarepossible in certaincases, but reasonshavetobestated • The workflowaccordingto the scientificguidelinesof the AWMF hastobeadaptedto the individual applicability in an individual situationaccordingto the parameters • indication • consultation, • preferences • participation in decisionmaking

  27. Classifications of AWMF guidelines AWMF: • S1: Recommendationsofscientific expert groups • S2: Guidelines based on evidence (S2e) orconsensusof a disciplinerepresentingcommittee (S2k) • S3: Guidelines based on evidenceaswellas on theconsensusof a disciplinerepresentingcommittee Remark: • In Germany itisimportantfor the doctorsliabilitytoobey in detailat least the S-3 guidelines (and a must togetsomecertificationslikeOnkoZert)

  28. Development process of AWMF-guidelines 5 stages in the lifeof a guideline (AWMF) Planningandorganisation Development of a guideline Editorial processand Publishing Implementation Evaluation andPlanningtheUpdating

  29. General and special Certification Schemes

  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. Yearlyconformity audits

  31. Certification status in acute hospitals Problems in statusassessment: • nopubliclyavailablesourceaboutprecisecertificationnumberssincecertification in acutehopitalsisvoluntarily • Eachcertifiedhospitalpromotesitsowncertification • Onlyactive KTQ certificationsarelistedpublicly • ISO certificationsare not releasedfromthecertificationorganisations • Private datasourcesabouthospitalsdiffer in definitionsfromthe Federal Authority ofStatistics Result: Wecouldevaluateforyouthecurrentcertificationsituationonly on a referencebasisofabout ¾ ofthe 2017 acutehospitals, namely in 1576, but wecanofferat least an overallviewofconclusions

  32. Certification status in acute hospitals • Numberof non-certifiedacutehospitalsis still predominant • Highestportionofcertifiedacutehospitalsis in the charitybasedownersector Source: DKA, 2012

  33. Market share of Certification Schemes Acutehospitals: • 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 publicacute 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

  38. Assessment after 20 years QM experience Preferredisstructured QM approachof ISO type but onlywithspecialtouchtomeet the healthsectorsneeds: • Development in the health-caresector in understandablelanguageof the healthcare professionals • Focus on patientorientation • Evidencebasedmedicine • Risk-management • Preventionofdefects and non-conformities • Usablefor all health-careorganisations • Forsmall and verycomplexorganisationswith all necessaryaspects (patientcare, medicalcompetence, clinicalpathways 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. (GKindDe.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

  42. Special Certification schemes of Associations

  43. Topics 3. Focusing different Certification Schemes

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

  45. KTQ – catalogue version 5.0 Categories • Patient-orientation in Patient Care • Ensuringemployees-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.gtumourboards) • Organ-specificdiagnostics • Radiology • Nuclearmedicine • SurgicalOncology • Chemotherapy/Internal Oncology • Radiooncology • Pathology • Palliative Care und Hospiceservice • Tumourdocumentation/Outcomequality

  49. Trauma Network - Requirements Compliance withrequirementsdefined in checklists: • Profile checklistforfacilitiesfor the Basic Treatment ofseverelyinjuredpersons • Checklist for a Regional Trauma Center • Profile Checklist for a Supraregional Trauma Center Requirements: • Personnelrequirements • Facility and equipmentrequirements • Measuresfor Quality Assurance

  50. Topics 4. External quality assurance

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