Oncological Centers & OnkoZert-Certification Scheme Deepening Topics Oncological Centers & OnkoZert-Certification Scheme

Example OnkoZert Certification: Topics Basics about OnkoZert Oncological Centers Benefit of an oncological center Requirements regarding Tumour Boards Areas for Improvements regarding Tumor Boards

Topic 1. Basics about OnkoZert

OnkoZert What‘s about OnkoZert? Independent facility in Neu-Ulm/Germany Developed the certification system of the German Cancer association (DKG) for organ cancer centers and oncological centers Certification on the basis of the medical requirements regarding the treatment of oncologial patients

Structure of oncologial treatment centers 3-Stages-model of the oncological treatment structure CCC = Comprehensive Cancer Center CCC Oncological Center Organ Cancer Center

Combi-model OnkoZert Interdisciplinary center: Separate legal personality 4 protagonists center (heads and coordinator) Main treatment partners/key treaters Other cooperation partners Private practices and specialists Point of intersection: Tumor board Central target: Consistent same quality regardless where the patient is transferred to the center

Combi-model OnkoZert QM-System verification OnkoZert-Certification Seperate network structure and independent QM system: ISO-Certification KTQ-certification Breast Center Abdominal Cancer Center Prostatic Cancer Center Skin Tumour Center Gynecological Cancer Center Main treatment partners Facilites Clinical pathways Lung Cancer Center ISO-Auditor for Systematic QM in Facilities as well as for QM on center level OnkoZert-Auditors for medico-scientific requirements

Main cooperation partner Treatment Care providers Combi-model OnkoZert Breast Cancer Center Abdominal Cancer Center Prostatic Cancer Center Main cooperation partner Treatment Care providers Operating Surgeon Gyn. Oncologist Radiologist Pathologist Internal Oncologist Radio-oncologist Nuklear Medicine Visceral Surgeon Gastroenterologist Treatment Care providers I Urologist (diagnostic +operative) Treatment Care providers II Urologist or Internal Oncologist (chemotherapy) Urologist (diagnostic)

Example: Key-Process of the abdominal center

OnkoZert-Requirements OnkoZert-Certification system: For interdisciplinary cancer centers Oncological Center with modules and oncological entities Summary of data in elicitation sheet Fulfilment of requirements in elicitation sheet necessary for certification Development and further development by interdisciplinary certification committees of the German Cancer association

Key figures / Quality indicators Documentation of the oncological treatment Definition of uniform and understandable organ-specific requirements, key-figures and quality indicators by the German Cancer association, e.g. Primary case Operations Complication Precondition to measure an increase in the treatments quality

Key figures / Quality indicators Documentation of the oncological patient treatment Key figures base on the actual S3 guidelines or guideline recommendations Evidence based Medicine: guideline implementations have to be verified by the clinics in the daily treatment regimes during the certification process

Process organisation of an Center Key- and Part Processes: Oncological patient treatment Registra- tion Admis-sion Diagnos- tic Therapy Release /Transfer After treatment

Intersections of the key-process: Oncological patient treatment Registra- tion Admis-sion Diagnos- tic Therapy Release /Transfer After treatment

Tumour Boards Target: Evaluation and staging of different tumour entities in a common interdisciplinary weekly conference on the basis of first diagnostic results Tumor Boards are the core structure for the requested interdisciplinary cooperation and treatment approach The discussion in TB follows established fixed rules Individual special Tumour Boards for special tumour entities are possible

Tumour Boards Recommendations of the interdisciplinary team must be based on the evidence based medicine and the guidelines or regulations of the medical-scientific associations Recommendations shold take reference to the guidelines. They shall not reformulate these new Workings out however of the local clinical diagnostic and treatment procedures (SOPs) along the guidelines are required (Transfer of guidelines into the daily actual clinical treatment)

Tasks of the Tumour Boards Recommendations in regard to further diagnostic, therapy and After-treatment procedures of individual patients Planning of the further treatment of certain tumour patients or patients with recidives in the interdisciplinary team Establishment and publication of the internal SOPs guidelines (SOPs) for the most important tumour diseases

Requiremants regarding the TB implementation Procedures to be regulated for the implementation of a Tumour Board Cycle Participants Patient presentation Preparation Procedure of the performance of aTumour Board Tasks after finishing a Tumour Board: Information and execution of the recommendations

Topic 2. Oncological Center

Impact of an Oncological Center Center for the evaluation and treatment of numeroues tumour enties Higher grade of specialisation: even the expertise for very rare diseases is focused in such a center Precondition for the first OC-certification: Integration of at least 2 organ cancer centers and of modules (brain, head, mouth etc.) Recertification (after 3 years): Integration of at least 3 organ cancer centers

Structure of an OC Oncological Cancer Center Board/ Steering Committee, Center-coordination, Secretariate Organ centers Breast center Abdominal cancer center Lung cancer center Further Cancer- Entities centers Gyn. Cancer Center Center for neuroendocrinal tumours Modules Head-Throat -Center Neuro-oncology Pancreas Cooperation- partners Psychooncology Study assistence Nurses Pathology Radiology Radio-onocology Hematology Oncology etc. External Cooperation Partners Clinics: General and Visceral Surgery, Gynecology and Obstetrics, ENT, Oral and maxillofacial surgery, Internal Medicine: all Departments, Thoracic surgery, endovascular surgery, Neuro-surgery

Rules of Order and development of the OC Clear targetting Set-up, organisational structure, personal of the OC Steering Committee Cooperation partners internal and external Operational and decision making procedures Core competencies and Tumour Boards Documentation of follow up of patients Quality Assurance Cost- and finance structure Action plans Public relations

3. Benefits from the Oncological Center Topic 3. Benefits from the Oncological Center

OC impact and benefit to clinics Oncological Center facilitates Use of synergies Facilitation of Clinical Research Interdisciplinarity Improved communication Technical and professional exchange Registra- tion Admission Diagnostic Therapy Release/ Transfer After treatment Continuous, standardized, transparent processes High therapeutic standards, prevention of failures

OC impact and benefit for clinics OC uses synergies in a region: General practicioners Self-help groups Specialists and Consultants Tumour register Physiotherapeutics Hospices Center for histopathology Social services Clerical services Ambulant nurses

OC-impact and benefit for centers Board and Steering committee regulates and synchronices the cooperation with the involved organ cancer centers Central coordination of the cooperation Central organisation of tumour boards Increase of patient orientation Benefit for the Centers: Systematic, positive influence of the synergies with the individual organ-centers and treatment structures

OC-impact and benefit for patients Patients with tumour diseases need holistic, interdisciplinary and continuous treatment. An Oncological Center ensures for: … also in rare and complex diseases Treatment with highest quality standard Frictionless outpatient and stationary treatment Inclusion of the patient Continuity of holistic and comprehensive treatment and ICF Interdisciplinary diagnosis and therapy

Patients treatment in OC

4. Requirements for Tumor Boards according to OnkoZert Topic 4. Requirements for Tumor Boards according to OnkoZert

Cycle and participants of Tumour Boards Cycle: Performance at least 1 x weekly Participants (competence level: senior consultants) Relevant diagnostic, surgical and chemotherpeutic expertise (organ-specific) Radio-oncology Hematology and Oncology Pathology Radiology

Demand-actuated Participants Following disciplines/professionals have to be adequately included into the Tumour Boards: Pharmacy  Nurses Surgery  Psychooncology Orthopetics  special pain treatment Neuro-surgery  Study coordination Neurology  Palliative Medicine

Special regulations Participation of cooperation partners in Tumour Boards: If different cooperation partners from same discipline work in the Tumor Board service, then the presence of one representative of the discipline is enough Condition for that: a regular information procedure is implemented (e.g. via quality circles) Independently thereof each cooperation partner has to participate at least in 30 % of the Tumour Boards in a year

Preparation Written summary of the patients data Distribution of the summary to the participants Select from the patients panel suitable study-patients Communication with the transfering practitioners: Admissioners are entitled to participate in the Tumour Boards, when their patients are evaluated They are entitled to present the clinical status and their clinical data of their patients in the Tumour Board

Presentation of Patient data All tumour patients data are to be presented in a formal procedure and sequence Organ-specific requirements Centers Moduls Main focuses Exemptions must be reasoned All patients with recidives and metastases

Performance Video conference Under special conditions possible (if special OnkoZert-requirements are met for equipment status and performance) Video conference system must be demostrated online in the certification audit The requirements of OnkoZert must be satisfied precisely e.g. visibility quality, evaluation possibility, speech quality, operation of system, compensation concept in malfunction

Performance Demonstration Image material Availability of patient related images (pathology and radiology) Suitable technical equipment for the presentation and demonstration of the images (computerized presentation)

Advanced education Mandatorily required is at least once a participation in the Tumour Boards of the following functions/ professionals: Assistence personal (MTA, TRA,…) from the functions radiology, nuclear-medicine, radio-oncology Social Service, Psychooncology, Pharmacy Specially oncology-trained nurses at least 2 for a treatment unit Refreshment at least all three years

Impact of the results of the Tumour Boards Plannings of treatment/recommendations of the Tumour Boards are binding Deviations from the original therapy planning and guidelines must be reasoned, documented and evaluated Adequate measures have to be taken, that deviations occur only in reasonable cinical situations Informed consent of the patient about the recommendations of the Tumour Board Therapy changes or abortion of the herapy according to the will of the patient have to be documented

Documentation of the Tumour Board The results of the Tumour Board is a written interdisciplinary treatment planning Becomes part of patients documentation Can be the content of the release letter to the transfering practitioner Documentation should be generated automatically from the electronic tumour information system Patient gets a copy of the documentation on demand

Topic 5. Some typical areas for improvements of the performance of a Tumour Board

Areas for Improvement 1. Central registration of patients with a minimum lead time Patient management OC

Areas for Improvement 2. Check of the patients documentation in OC regarding completeness. Demanding missing informations and results

Areas for Improvement 3. Distribution of a list with the patients together with the informations and results to the participants in adequate time before the Tumour Board for their preparation

Areas for Improvement 4. Self-preparation of the participants of the Tumour Board on the basis of the documention and possibly their own clinical knowledge of the patient

Areas for Improvement 5. Room equipment and sitting order of the participants

Areas for Improvement 6. Leading of a Tumor Board by a Board member (Clinical Directors) of the Center or his Deputy

Areas for Improvement 7. Presentation of the patient after request of the head of the TB by a participant with the discipline nearest to the indication 8. Calling upon the patients along the prepared list 9. Concurrent documentation with concurrent control via beamer checking by the participants

Areas for Improvement 10. Perfect images of highest quality of the pathologists and radiologists

Areas for Improvement 11. Explanation of the pathological results by the pathologist and radiologist 12. Video conferences

Areas for Improvement 13. Inclusion of the clinical knowledge about the patient by a presentation of the practicioner specialist if present

Areas for Improvement 14. Summary documentation of all recommendations of the Tumour Board as well as a separate documentation on the treatment of a single patient. The summary document has to be signed by each participant. The individual patients document is to be signed by the Head of the Tumour Board.

Areas for Improvement 15. The decision of the Tumour Board regarding the recommendation for a treatment of a patient must be clear, unmistakably and complete and shall constitute the strategic treatment planning.

Areas for Improvement 16. The individual patient document with the Tumor Board decision shall become part of the patient file. The decision shall also be cited in the transfering letter to the practitioner as the essential treatment target.

Areas for Improvement 17. Informed Consent of the patient about the recommendations of the Tumour Board for obtaining his consent to this treatment