Quality Management in Tissue Medicine

DGFG’s Central Quality Management (QM) monitors the entire process of tissue donation – from donor identification to transplantation at the recipient’s site. The aim is to ensure that the tissue donation in the sense of the donor and the transplant recipient complies with the law and follows standardised procedures.

According to § 32 paragraph 1 of the AMWHV (Arzneimittel- und Wirkstoffherstellungsverordnung), the QM of the DGFG ensures, among other things, that the employees carry out and document all work processes that affect the quality and safety of tissues and tissue preparations under controlled conditions. The central QM department takes over the quality management of the tissue banks completely or advises and supports the tissue banks of the entire DGFG network within the scope of cooperations in the implementation on site. The Central QM also accompanies the inspections according to § 64 AMG by the local state authorities.

Tasks of the Quality Management

Low discard ratios – a performance benchmark for quality management

Based on good professional practice, a QM manual in the DGFG quality management system describes all quality-relevant processes including quality assurance and tissue traceability. The QM continuously checks the manual as well as the processes in practical use. If necessary, it adapts them to the state of the art in science and technology.

DGFG’s quality management ensures that all processes in tissue donation are carried out in accordance with the law and reliably for both donor and recipient.

Commendation and complaint management

A further task of the entral Quality Management is the systematic documentation and analysis of all deviations that may occur during the individual processes of tissue donation. Correspondingly adapted immediate, corrective and preventive measures (CAPA) ensure continuous improvement of processes and transplant quality.

Despite all the control mechanisms and diligence of every single employee in the DGFG network, errors may occur. It is important that they are not repeated!

The DGFG has established a system that enables both the partners of the tissue network and the transplanting clinics to give us direct feedback on commendations and complaints. The DGFG is grateful for any feedback. The central QM analyses every single report. The total number of complaints is extremely low in relation to the total number of all transactions.

Satisfaction with corneal grafts (by surgeons)
201520162017
Allocated cornea2.7093.0423.148
Complaints191325
2017
Allocated cornea3.148
Complaints25

Many partners praise the good cooperation as well as the quality and safety of the transplants. The positive feedback the DGFG has received in recent years has been largely due to the good quality of the tissue and the smooth cooperation between the DGFG and the transplanting clinics.

Perfect quality! Thank you!

PD Dr. Dr. med. habil. Sasa-Marcel MaksanChief Physician, Hochtaunus Kliniken gGmbH

It all worked out perfectly. Very nice graft. The patient is fine.

Dr. med. Knut P. WalluscheckChief physician, Diakonissenkrankenhaus Flensburg

Good condition! Thanks for the quick help!

Dr. med. Jan KöhlerSenior physician, KRH Klinikum Region Hannover – Klinikum Nordstadt