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
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
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.
information on the international certification system can be accessed
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.
Tel.: +49 (0)7 31
/ 70 51 16 - 30
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.
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
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
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.
centres, the patients are treated integrative and in all stages of the
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
For this purpose,
the medical professional societies for specific organs (breast,
intestine, prostate, ...) have established specific professional
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
information about the certification
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.
“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)
||The Regulations for implementing the
certification are established among others in the following documents:
“General certification terms” (Status 24.08.2018)
“Dispositions regarding data quality” (Status 24.08.2018)
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
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
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
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)
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
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
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
For definitions of time limits, please note the next section “Handing
over the Catalogue of Requirements including annexes” (valid from the
audit year 2016)”
over the Catalogue of Requirements including annexes
|| Definition of the questionnaire’s
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 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
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
- 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”
- Certified Oncology Centers with an extension of a Prostate Cancer
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).
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).
|| 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
|| 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
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.
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.
|| 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.
|| 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’
|| 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.
oncology organ centres
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.
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.
for cooperating Organ Cancer Centres
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.
initial certifications of multiple locations
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 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.
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.
for evaluation of structure
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 of cooperating locations is an advantage.
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
of the cooperating locations
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
of primary cases
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.
of QM (quality management) system
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.
integrated cooperation partners a centre has, the more difficult the
coordination in the centre and between the cooperation partners of a
of the Certification System
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.
certification commission (legislative)
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
Award Committee (judiciary)
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
The issuance of a certificate requires the approval of the Certificate
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 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.