Quality policy

The Institute of Medical Microbiology and Hygiene has implemented a comprehensive quality management system to guarantee a high standard of medical microbiological laboratory diagnostics and to ensure that the laboratory's services, including consultation and assessment of findings, meet the needs of patients and clinical staff. Key elements of the Institute's quality management system include

  • The definition of the laboratory's range of services, including the obligation not to carry out any non-specialist tests
  • the commitment to good professional practice and quality
  • the definition of a quality policy based on quality objectives
  • approx. 500 procedural and standard operating procedures (SOPs), in which the microbiological tests performed, methods and the operation of facilities and equipment, including responsibilities from sampling to reporting findings, are defined and presented in a binding manner
  • Internal and external audits and quality controls to ensure that the established quality management system is fully realised in practice
  • A quality circle of committed employees that meets regularly to discuss current quality assurance problems
  • Quality management assessments to analyse whether the established quality regulations continue to meet both the needs of the laboratory and the requirements of the standards
  • Comprehensive complaints and error management

The quality policy of the Institute for Medical Microbiology and Hygieneis embedded in the measures of the hospital management board and the quality management staff unit. The aim of this is to establish a comprehensive quality management system for the entire Ulm University Hospital.

In addition, the quality policy of the institute and laboratory management pursues its own quality objectives, which are intended to ensure that the tasks and requirements of the laboratory are fulfilled to the highest quality, taking into account all requirements of the applicable standards, structural changes and constant scientific progress:

  • The provision of high-quality diagnostics that take into account the current state of scientific knowledge, follow the recommendations of the professional societies, in particular the German Society for Hygiene and Microbiology(DGHM), and comply with legal requirements (Infection Protection Act, Biological Substances Ordinance) and guidelines(Robert Koch Institute).
  • The provision of rapid and targeted diagnostics; this also includes the avoidance of redundant/unindicated tests or tests with no prospect of success if the test material is unsuitable.

  • The provision of reliable diagnostics through quality assurance measures

  • Rapid availability of microbiological laboratory results for the clinician.

  • Competent counselling of senders and facilities of the University Hospital.

  • The highest possible employee qualification through further education and training programmes

  • Maximum employee participation by involving them in change measures and ensuring acceptance.

  • Protecting employees from health hazards when handling microorganisms and potentially infectious test material.

  • Maintaining the independence and integrity of the laboratory by keeping the laboratory and its staff free from commercial, financial or other influences so as not to influence professional judgement or negatively affect the scope and required quality of the test results provided.

In compliance with these quality objectives, the management undertakes to fulfil DIN EN ISO/IEC 17025 and DIN 15189 and thus to ensure good professional practice and quality.

Accreditation

The diagnostic laboratory and the clinical hygiene section of the Institute of Medical Microbiology and Hygiene have been accredited by the German Accreditation Centre(DakkS) since December 2002.
In contrast to certification, accreditation requires not only the establishment and maintenance of a quality management system, but also proof of a high standard of microbiological diagnostics at all levels, including pre- and post-analysis and the interpretation of findings (see also Quality Policy).
Accreditation initially took place in December 2002 in accordance with DIN EN ISO/IEC 17025, but the diagnostic laboratory was reaccredited in June 2004 in accordance with DIN EN ISO 15189, a new standard specific to medical laboratories that defines "Special requirements for quality and competence for medical laboratories". The area of drinking water testing is still accredited in accordance with DIN EN ISO/IEC 17025.
DIN EN ISO 15189 specifies and extends DIN EN ISO/IEC 17025 with regard to the quality-related requirements for medical laboratories, particularly in the following areas:

  • Evaluation and improvement of the quality management system
  • Preanalytics and postanalytics
  • Customer orientation
  • Employee competence
  • Training (education, training and further training) of staff


The quality management system of the Institute of Medical Microbiology and Hygiene in accordance with DIN EN ISO 15189 thus ensures continuous monitoring and improvement of quality and adaptation of microbiological diagnostics to constantly changing scientific findings. This high quality was last certified by the DakkS in May 2022 as part of the reaccreditation process.

Quality indicators

The Institute of Medical Microbiology and Hygiene endeavours to make the Institute's quality objectives transparent and measurable. To this end, quality indicators have been defined, which are analysed and redefined annually. The quality indicators for 2023 include

  • Obtaining a certificate in 90% of all participating round robin tests
  • Organisation of internal training courses, approx. every 6 weeks
  • Production of at least 6 peer-reviewed publications on microbiology, infectiology or immunology topics in German or international journals
  • Preparation of incorrect diagnostic findings in < 0.1 % of all findings
  • The proportion of technical staff with specialised training (e.g. MTL) should be 100%.

Interlaboratory test certificates

The Institute of Medical Microbiology and Hygiene regularly takes part in the external quality controls (round robin tests) offered by the Institute for Standardisation and Documentation in Medical Laboratories (INSTAND).
If you are interested in participating in clinical studies, certification or accreditation endeavours, etc., please contact us. If you require copies of the proficiency test certificates for participation in clinical studies, certification or accreditation endeavours, etc., please contact the Institute's quality management officers directly.

Activities in the area of quality management

In addition to the continuous maintenance and optimisation of the Institute's internal quality management system, the employees of the Institute of Medical Microbiology and Hygiene are also actively involved in external events on quality-related aspects:

  • Participation in further training and exchange of experience at the DAkkS
  • Continuous quality circle A-Team

Quality Management Officer

QMB Microbiological Diagnostics

  • Sonja Maier

    QMB

    Schwerpunkte

    Qualitätsmanagement Diagnostik

    MTL Molekularbiologie

     

QMB Hospital Hygiene