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.
The Regulations for implementing the certification are established among others in the following documents:
QM Systems (Quality Management)
In the DKG-certified centres, a certified quality management system (QM system) should be implemented. According to the Letter from the German Cancer Society from 07.12.2016 there is no obligation for the certification of a QM system.
Center planning: Continuation of QM certification
If the recommendation is followed to continue the certification of the QM system, then combined certification procedures ISO 9001 / OnkoZert are still possible.
Center planning: No continuation of QM certification
Since QM certifications generally include contractual agreements with the QM certification bodies, these must be taken into account when concluding an existing QM certification or must be clarified with the respective QM certification body.
For the DKG certification system and thus also for OnkoZert, apart from a short message about the non-continuation of the QM certification, no special features have to be considered.
Ongoing initial certifications
These regulations also apply to current initial certifications.
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”.
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 (e.g. 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 (i.e. before such a cooperation agreement), to consider the principle certification ability as well as other features.
Submitting the application
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
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.
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 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).
– 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).
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 submitted.
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.
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.
Reduced audit cycle (REDZYK)
A certified center, which has achieved above average results in the past, can request a reduction of the audit cycle. A reduction in the audit cycle means that as an alternative to an on-site audit, the certification requirements are considered through a document review. Exceptions to this are re-audits, which must be carried out in advance of a possible extension of the certificate.
The procedure “reduced audit cycle” is divided into two parts. As a first step, OnkoZert assesses the formal requirements for the reduction of the audit cycle by deciding whether the centre meets the requirements for the reduced audit cycle. The prerequisites are explained from the third page of the document “Provisions and Application reduction of the audit cycle” (Status 28.09.2023).
The final evaluation “reduction of the audit cycle” is carried out by the Certificate Awarding Committee. For this all necessary documents must be available (current Catalogue of Requirements including Data Sheet, statement about audit report, and possibly further evidence). For all further information on the procedure, please refer to the document “Provisions and Application reduction of the audit cycle”.
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.