OnkoZert


OnkoZert is an independent institute for quality assurance and data management in medicine. As the mandate holder of the German Cancer Society (DKG) we have been involved in certifying oncological care facilities for more than 10 years. Against this backdrop, we handle the certification process and the associated data management on the national and international level for more than 1,200 oncological care facilities. The focus is on improving the care of cancer patients. To this end, we promote interdisciplinary care structures and make process and outcome quality measurable.

 

 

Certification


Thanks to the certification system, the quality of both Organ Cancer Centres (Breast Cancer Centres, Colorectal Cancer Centres, etc.) and overarching care networks (Oncology Centres, Visceral Oncology Centres, etc.) can be documented externally. Certification is undertaken in line with the specific requirements of the German Cancer Society and several medical associations.

In 2017 the German Cancer Society launched programmes that permit international certification with due consideration of national factors. Currently, almost 100 oncological care facilities outside Germany are participating in the certification process.

More detailed information on the international certification system can be accessed on: www.ecc-cert.org. If you have plans for or a concrete interest in certification outside Germany, we kindly ask you to contact us directly by email or phone.

Contact  OnkoZert:

Email: info@onkozert.de

Tel.: +49 (0)7 31 / 70 51 16 - 0

 

 

Data management institute


OnkoZert develops and operates several IT solutions and internet platforms. Our data management institute continuously works on developing our existing products and new projects.

The Internet platforms, OncoMap and StudyBox, provide information for practitioners and patients. The PCO-Study, which was nominated for the HEALTH-i Award by the Handelsblatt newspaper, monitors prostate cancer patients in an international comparison.

OncoBox enables care facilities and research institutes to compare their data. The secure OncoBox connection to more than 30 different tumour documentation systems makes it possible to map the individual case data of over 140,000 cancer patients in a standardized database structure in the certification systems of the Breast, Colorectal and Prostate Cancer Centres.

 

 

General information


OnkoZert is an independent institute which supervises, on behalf of the German Cancer Society, the certification system for the verification of organ cancer centres and oncology centres, according to the relevant technical requirements. The aim of the German Cancer Society (DKG) and other medical societies is to promote the development of oncological centres with an established qualitative demand, on a voluntary basis and therefore to improve the care of cancer patients.

 

In oncology centres, the patients are treated integrative and in all stages of the disease.

 

An integrative care of patients is possible only through a network of specialists of different medical and nursing disciplines, in which the study fields align their working methods according to the needs of optimal patient care.

 

For this purpose, the medical professional societies for specific organs (breast, intestine, prostate, ...) have established specific professional requirements.

 

Oncology-specialized health care facilities have the possibility to review the fulfillment of the technical requirements as part of a certification procedure. Upon successful completion of the certification procedure, the health care facility will be confirmed, through an issued certificate, as an Organ Cancer Center (such as a Breast Cancer Center, Colorectal Cancer Center), recognized by the German Cancer Society (DKG) and other medical professional societies.

 

 

Phases of certification

 

Basic information about the certification The document "Basic information regarding certification" contains basic information and experiences related to the certification of the organ centres, which must be respected especially prior to the organization of the certification of a centre.
The analysis of the document "Basic information regarding certification", which contains central observations concerning the structural requirements of the centre, is highly recommended as early as possible during the planning of an Organ Cancer Center.

Download “Basic information regarding certification” (Status 24.08.2018)
Download “Defining the cooperation partners” (Status 24.08.2018)
Download “Directive on assigning names to the Centres” (Status 24.08.2018)

Certification terms The Regulations for implementing the certification are established among others in the following documents:

Download “General certification terms” (Status 24.08.2018)
Download “Dispositions regarding data quality” (Status 24.08.2018)

Oncology Centrestress For the certification of oncology centres, including the modules (head-neck, neuro-oncology,...), special additional features must be taken into consideration, that can be accessed on this homepage in the menu "Oncology centers”.
Application For the initiation of a certification procedure at OnkoZert certain data is needed. These data are transmitted by the interested centre through an application form. OnkoZert evaluates the principle certification capacity of the structure of the centre and estimates the certification costs.

Recommendation in time: 4-6 months prior to the planned audit term

Centres with multiple locations:
Merging multiple locations into a common center is possible for certain organ cancer centres (eg breast and colon). This is however linked to certain prerequisites, which are partially presented in the Catalogue of Requirements specific to the organ. For the admission to the certification of a structure with multiple locations, the completion of an assessment of the structure with a positive result is mandatory.

If you take into consideration a structure with multiple locations, please contact OnkoZert as soon as possible (ie before such a cooperation agreement), to consider the principle certification ability as well as other features

Download “Directive on the evaluation of primary cases/number of cases (directive on primary cases)” (Status 24.08.2018)

Submitting the applicationn Once the application was submitted in written form by the Centre, the certification will be formally initiated. After this, the specialized experts will be named and the dates for the audit will be established. A confirmation of the audit date involves the availability of the necessary specialized experts.

Recommendation in time: 3-4 months prior to the planned audit term

Download “Application for the beginning of the certification procedure” (Status 24.08.2018)

Evaluation of the Catalogue of Requirements The requirements for a centre are set in the Catalogue of Requirements specific to the organs. In the Catalogue of Requirements, the centres that are in certification preparation, describe how the individual requirements are transposed in the centre. The Catalogue of Requirements processed by the centre will be handed over to OnkoZert and will be evaluated by the specialty expert in terms of fulfilment of requirements. In the evaluation issued in writing by the specialized expert, a recommendation will be issued regarding the initiation of the certification procedure. The evaluation can be put together with the documents related to the certification initiation procedure.
The centre can use this evaluation for a new targeted focus on clarifying or removing the described weak points, for the preparation of the certification audit.
The centres in which the successful certification is seriously jeopardized, will thus be early protected by a certification with negative results.

Data sheet:
The "Data sheet" is an official annex of the Catalogue of Requirements and will be handed over simultaneously with the Catalogue of Requirements. In a first step of evaluation, this document with indicators will be assessed formally by OnkoZert. In a second step of assessment an analytical analysis of indicators follows, through the specialized expert.

For definitions of time limits, please note the next section “Handing over the Catalogue of Requirements including annexes” (valid from the audit year 2016)”
Handing over the Catalogue of Requirements including annexes Definition of the questionnaire’s annex

In addition to the data sheet (Excel-template), official questionnaire’s annexes may also contain other documents. Obligatory are for example, the master data sheet and for the Oncology Centers the Certcalculator and if applicable also the tumor entity unit (level of competence “T” and “S”). In individual cases, the cut-off period may also be subject to statements expressly requested by OnkoZert (for example on the primary case development).

Time limits:
• Time limit of the initial certification: 6 weeks before the scheduled audit date; for Oncology Centers: 8 weeks.
• Time limit of the re-audit*): 6 weeks before the scheduled audit date
• Time limit of the follow-up/re-audit: 4 weeks before the scheduled audit date

Re-audits*) with modular system approach

The time limit corresponds to the initial certification. A document check is only possible if the processing of the certification’s request, is concluded with a positive result (the recommended timeline for the submission of the request: 4-6 months before the scheduled audit date).

For example:
- Existing Visceral Oncology Centers with Colorectal and Pancreas Organ Cancer Centres with a plan of extension with Gastric Organs
- Certified Oncology Centers with an extension of a “Head/Neck-Tumor” module
- Certified Oncology Centers with an extension of a Prostate Cancer Centre

Completeness of the documents (Admission requirements to the audit)

Irrespective of the type of audit (initial certification, follow-up, re-audit) the completeness of the documents is a requirement for the admission to the audit. Completeness means that all required documents are in full and correct form within the time limits. The submission of individual documents due to incomplete processing is not possible after the timeline frame (the beginning of the document’s verification process requires completeness).

Submission format:
The documents are sometimes read automatically in the databases. Therefore, a submission in the original file format is required (for example, Word or Excel; PDF formats are not possible).
Preliminary Discussion In a preliminary discussion the uncertainties and the critical points, which can affect the success of a certification, between the centre and the specialized experts, are regarded on-site. A preliminary discussion is recommended especially when there are doubts / uncertainties, which could jeopardize a successful outcome of the audit. This can be for example in the case of complex structures (centre with multiple locations, ...), or when the construction of the centre cannot use the experiences with the DKG certification system. The preliminary discussion lasts between 0.5 and 1 day and will be negotiated with OnkoZert when the request is submitted.
Certification on-site The development in time of the certification will be determined based on an audit plan, which will be developed by the specialized expert on common consent with the centre. The specialized experts inspect in the certification audit the various domains of the centre. Inspections of the external cooperation partners are also conducted. Based on the information given by the centre in the Catalogue of Requirements, it will be checked by specialized experts if the requirements are met by examining various documents and by discussions with the staff. On-site certification audit ends with the final discussion, in which the specialized expert presents the result of the audit and gives a recommendation for the release of the certificate.
Evaluating the elimination of irregularities If in the certification audit deviations from requirements are found, these must be eliminated by the centre within a period (max.3 months). The eliminating of deviations will be assessed by the specialized expert. This occurs in the form of document evaluation or a subsequent audit on-site.
Evaluation by the Certificate Awarding Committee The specialty expert is authorized only to make a recommendation on granting the certificate. The final award of the certificate takes place by a commission that releases the certificate, which usually follows the recommendations of the specialty expert. Through the commission that grants the certificate, there can be set additional requirements, which are preconditions for the release of the certificate.
Releasing the certificate After a positive answer from the commission that grants the certificate, the certificate may be released. The design of the certificate and its delivery method will be established with the centre.
Surveillance audit Meeting the requirements and the further development of the centre will be checked annually, at random, by specialized experts on-site. The centre will have to hand over to OnkoZert in advance (about 4 weeks) the updated Catalogue of Requirements (including the annexes). The main point to these surveillance audits is represented, among others, by the indications / observations in the last audit reports as well as the indicators’ situation.
Re-audit The validity period of the certification is 3 years. Before expiry of the validity, the checked centre shall be subject to a verification, which is similar, in terms of application and approach, to an initial certification.

 

 

Cooperative locations

 

Cooperative oncology organ centres A cooperative Organ Cancer Centre (eg breast, colon) is a union of several (clinics-) locations in a centre, which provides a basic care for oncology patients specific to the organ, appropriate to the requirements. Basic care includes especially diagnostic therapy (examination), surgery and inpatient treatment.


 

Partnership instead Cooperation The establishment of cooperation centres is often underestimated by participants, in terms of effort and requirements. Basically, cooperations should be an exception, especially when the participating hospitals have different owners. Generally, a collaboration between centres is possible (e.g. common tumour conferences) even without starting a cooperation.
Requirements for cooperating Organ Cancer Centres The purpose of a cooperative Organ Cancer Centre is a comparable patient care, in terms of method and quality. This means that the patients, can expect this comparable care regardless the hospital-location. A cooperating location has to prove entirely also the fulfilment of the requests of certification.
Simultaneous initial certifications of multiple locations The simultaneous initial certifications of several locations shall be avoided. In the case of cooperating locations, an already successfully certified centre is usually extended with a new location. A simultaneous initial certification is possible only in case of very positive structural conditions (including identical carriers).
Structural Requirements For the structural design of Organ Cancer Centres the document "Basic information for certification" contains important indications and structural requirements. This document has to be analysed in detail as soon as possible in planning an Organ Cancer Centre and has a great importance for the cooperating locations. The integration of OnkoZert in planning a cooperative centre also needs to take place very soon. It must be definitely prevented that in a moment in which many preliminary works have already been carried out, to question the principle structure of the cooperating centre.
Evaluation of structure Each cooperation requires a written assessment of the structure, which will decide on the admission of cooperation (subject to fees). Evaluating the structure is a costly and time consuming process, in which the requirements for the structural and central certification will be well analysed and evaluated. For the evaluation of the structure there are special templates, that will be asked for directly from OnkoZert.
Guidelines for evaluation of structure The evaluation of the structure conducted by the Certificate Award Committee will be made, among the guidelines presented below. These guidelines do not represent a criterion for exclusion from the admission to the certification procedure. In justified exceptional cases, the Certificate Award Committee may issue a special admission, in connection with certain requirements.
Holder A common holder of cooperating locations is an advantage.
Distance The distance of the locations compared to the main location must not exceed 45 km, respectively a route of 45 min. (calculated by Google Maps - the fastest route).
Number of the cooperating locations Each additional location increases the requirements and costs of a collaboration. Exceptions may be locations that are under the same owner and that are disciplinary driven by a medical leadership.
- 2 locations: Has been proven in some cases as a significant and useful structure for all parties involved.
- 3 locations: Can be difficult and to the extent possible, not be regarded as a preferred embodiment. If certain aspects are taken into consideration, this model can still be advantageous.
- 4 locations: Request in terms of coordination extreme claims, therefore it is generally not recommended. - More than 4 locations: A cooperation centre with more than 4 locations is considered to be highly critical based on actual experiences and it is absolutely not recommended.
Number of primary cases Each location of a cooperative centre must independently prove the case / primary case requirements. With regard to exemptions in the area of Breast (preservation of the status quo) and Lung (continuity of the centre management) OnkoZert is to be contacted directly.
Type of QM (quality management) system DKG-certified centres should implement a certified QM system, but there is no obligation to certify a QM system. Different types of QM systems at the locations are disadvantageous (e.g., 2 KTQ sites and one ISO 9001 site). If the cooperating centre consists of more than 2 locations, it is advisable to have a cross-location QM system in which the cooperation between the locations is regulated and controlled.
Cooperation Partner The more integrated cooperation partners a centre has, the more difficult the coordination in the centre and between the cooperation partners of a discipline is.

 

 

Board of the Certification System

 

Professional societies The German Cancer Society (DKG) is the carrier of the certification system. Professional societies and the DKG provide the politics and directions for further development of the certification system. They are also responsible for the supervision of this system.
The certification commission (legislative) The certification commission is the political organ of the certification system and is therefore entitled to define the requirements for certification. This includes in particular the design of the requirements (Certification Criteria) and their further development.

Members of the Certification Commission are the representatives of professional associations involved in the interdisciplinary care and social stakeholders such as Self-help groups. The management of the Certification Commission takes place in the office of the German Cancer Society.
Certificate Award Committee (judiciary) The Certificate Award Committee is a body independent of the audit implementation, which verifies every certification procedure for correct implementation, based on the audit documents provided by the professional experts.

The issuance of a certificate requires the approval of the Certificate Award Committee.
OnkoZert (executive) The management of the certification process and thus the executive administration of the certification system is carried out by the independent certification institute OnkoZert. The experience from the certification procedures are prepared by OnkoZert and made available for the Certification Commission for further development of the certification system.
Professional experts (Auditors) The certification of the Oncology Centres and Organs Cancer Centres is carried out by professional experts (auditors). These auditors must undergo a qualification procedure on several levels, and at the end of their successful development they are called auditors by the German Cancer Society. The qualification procedure as a professional expert requires, among others, the participation to an auditor course with final qualification testing, proof of certain admission requirements as well as the successful participation in an internship.