The Implementation of a Quality Management System (QMS) According to FACT-Jacie Standards Improves the Safety Level in the Collection, Processing and Clinical Departments of the Bone Marrow Transplantation Program

The establishment of a Quality Management System (QMS) according to FACT – JACIE standards in a BMT center is a very laborious project. Involvement of all personnel implicated in collection, processing and clinical procedures is absolutely necessary. Involvement includes strategic scheduling of QMS development, writing of SOPs and documents, and implementation of the system. Deviations from the system as errors, accidents and adverse reactions are very important to be reported in a way to make corrections and improvement in the system.

In our BMT center the duration of the task from the beginning to the application for JACIE accreditation was four years. A team of QM specialists was hired to work for the common project. Doctors, nurses, technicians and the QM specialists attended JACIE courses for center preparation. Writing of SOPs and documents was shared between the different departments. The QMS was implemented for the first time in June 2012. Audit of JACIE inspectors was performed in March 2013 and the center was fully accredited in October 2013.

During this task the personnel of the center acquired a lot of experience regarding SOP management especially in the field of deviations from the system. Errors, accidents and adverse reactions were completely reported and internal audits were for this purpose. Following the incidences in the three different phases: 1) organizing the QMS, 2) implementation – JACIE inspection and 3) post-inspection we realized that the number of deviations reported was completely different. There was an increase in the number of deviations reported during the second phase starting at the implementation and getting a peak during JACIE inspection. There was a 3fold increase compared to phase 1. During the 3^rd phase the number of deviations reported has a decrease and it is in a 2fold lower level compared to the peak of phase 2. Internal audits and inspections have documented that this is due to corrections and improvements of the system and the behavior of the personnel and not due to relaxing which is an achievement for our center.

In conclusion recording and dealing with adverse events as well as reducing the actual number of deviations, as a result of the better training and programming, could be a major factor that improves the safety level.