Quality office
Accreditation or certification will increasingly be required for internationally collaborative clinical and translational research projects. Well-defined “quality systems” enhance professional and effective use of resources and available research time. In addition it can enhance creative collaborative research processes and increase funding possibilities and collaboration with industrial partners. Therefore, the Department of Medical Oncology has initiated the development of a Quality System in 2007 to support four main scientific areas:
1. Translational Genomics and Proteomics of Cancer
2. Translational Pharmacology
3. Translational Tumor Immunology
4. Palliative and Supportive Care
Our expectation is that by 2015, not only clinical diagnostic procedures, but also clinical and fundamental research procedures will be required to have implemented a quality system.
The general goals of the Quality System are:
- sharing knowledge among the different research groups
- collaboration in the use of similar and comparable procedures
- technology transfer between research groups
- development of a quality plan for each research group and the Medical Oncology Department as a whole.
Management of the Quality System:
- to make recommendations to optimize collaboration between research groups
- to contribute to the implementation of Erasmus MC’s 5-year plan, “Koers’013”. The idea of this plan is “Together in Connection”. The vision on quality systems of Erasmus MC is “Aiming together to improvement."
- to present the mission and the accompanying strategy of the Department of Medical Oncology to all co-workers of the research groups
- to create a discussion forum for common strategic and quality management issues between the research groups.
Specific goals:
- to improve collaboration between the research groups and the implementation of quality initiatives in all research groups
- to improve the collaboration between the Department of Medical Oncology and other Departments / research groups within the Erasmus MC.
What has been achieved?
One research group (i.e., clinical tumor immunology) has a quality system implemented for (i) immunological diagnosis of hematological malignancies; (ii) immune monitoring (cellular and humoral) and (iii) cell preparation for immunotherapy. This quality system is CCKL accredited (“Medical Laboratories particular requirements for quality and competence”) and is based on the standard EN/ISO 15189.
A second research group (i.e., pharmacokinetics) performs experimental work in the setting of contract research in compliance with the OECD principles of good laboratory practice (GLP-accredited). Currently, the remaining research groups do not yet have a quality system operational. In order to define a working plan, a so-called “zero assessment” has been conducted within the scientific unit “Prognostic and Predictive factors in Cancer”.
Working plan to complete a Quality System for Medical Oncology
A “quality office”, consisting of 4 employees (2 research coordinators and 2 quality consultants) has been assigned to coordinate the project. “Task forces” have been formed by this office and so-called “process analyses” for each procedure have been started from October 2008 onwards. These analyses are planned to be completed by July 2009.
The process analyses include the definition and description of the primary processes within the research groups of the Department. These analyses are achieved through the formation of “task forces”. A “zero assessment” is generated for each process. By this zero assessment plans for improvement are defined. Essential points are the sharing of knowledge, to maintain, and further improve what is regarded as valuable. The following points are essential in the process analyses:
- description of the main process
- input/output analysis
- define hallmarks and standards
- definition of materials and methods
- tools for correction during the process; corrective actions
- indicators and tools for measurement
- definition of tasks, responsibilities and authorities
- inventory of “bottlenecks.”
Thus far, 4 task forces have been defined in a “bottom-up”-oriented approach, addressing the following fields:
- RT-PCR
- Immuno-assays
- Tissue culturing
- Registration (of instrumentation and procedures)
Depending on the operational processes performed by each research group, further task forces may need to be established.
A formal “business plan” will be offered to the Department’s leadership on short notice, containing:
- description of responsibilities and “go/no-go” points
- an overview of the research groups that wish to implement a quality system within a predefined time line
- a plan of investments in personnel to implement the quality system by these research groups
- a proposal for a transparent departmental organization structure (e.g., the model developed by the Dutch Quality Institute [Instituut Nederlandse Kwaliteit; INK])
The establishment of a Quality System by all collaborating research groups is a continuing process and depends on investments and the efficacy of the system. The zero assessment helps in defining this efficacy of the “Quality System” and defines the expected time of return of investment. To make this time point as soon as possible a full compliance to the generation of the “Quality System” is needed by the whole departmental organization structure.