Introduction
The Royal Decree (RD) of the 5th December 2011, concerning the licenses of anatomic pathology laboratories came into force the 1th March 2013. The purpose of this RD is to monitor and guarantee the quality of the Belgian laboratories for anatomic pathology. Since the 1th March 2014 all Belgian anatomic pathology laboratories are licensed. Within the framework of this licensing the laboratories are obliged to elaborate a quality management system within five years. However, the requirements concerning topics like access/safety and hygiene, maintenance and calibration of equipment, management of quality documents and method validation, transmission and confidentiality of patient reports, content of patient reports and management and validation of computerized systems as stated in the articles 22, 24, 26, 27, 28 and 29 of the RD, respectively, should be fulfilled within a time period of three months counting from the entry into force of the license. Additionally, participation in the national external quality assessment program organized by the Belgian Scientific Institute of Public Health (IPH) is also required by law.
Aim
In order to follow up the implementation of the quality management system and the implementation of the articles 22, 24, 26, 27, 28 and 29 of the RD in the Belgian anatomic pathology laboratories, a documentary audit by the department Quality of Medical Laboratories at the IPH has been performed.
Methods
In 2014, in collaboration with the Commission of Anatomic Pathology, all licensed laboratories were asked to fill out a table in which the percentages of implementation of each article (22/24/26/27/28/29) had to be indicated. In addition, the laboratories were requested to indicate for each item and article the corresponding Standard Operating Procedures (SOPs) and validity date.
In the course of 2015, during a second evaluation step, the laboratories were asked to actualize the table presented in the survey of 2014. In addition, some specific quality documents were requested as well, in particular the patient reports and the SOPs concerning the management of the quality documents and on equipment management.
The tables, patient reports and SOPs were evaluated substantively for the presence of predefined items after which the percentage implementation for each article (only for the evaluation of the tables) and an overall score were calculated.
Results
From the installation of the RD till 2015, the number of licensed laboratories diminished from 102 in 2013 to 85 in 2015, mostly due to cessation of laboratories of connexists ( specialist physicians who perform acts of anatomic pathology exclusively for their own patients).
In 2014, 96 laboratories were included in the evaluation survey and 59 participants (61%) obtained an overall implementation score (all articles includes) of more than 70%. During the second evaluation survey organized in 2015, among the 85 included laboratories, 77 (80%) received an overall implementation score of more than 70%.
In 2014 we counted 16 laboratories (16.6%) with an overall score of less than 25% as compared with 2015, in which no single laboratory scored less than 25%.
More detailed analysis of the obtained information revealed that the procedures on validation of methods and on management and validation of computerized systems seemed to be an issue. In 2014, only 56% of all laboratories had completely implemented the SOP on validation of methods, in contrast with 73% of the laboratories in 2015. In particular the implementation of article 29 (management and validation of computerized systems) seems to remain the biggest obstacle as only 30% of the laboratories had completely implemented this article in 2014 and still one third of all the laboratories are lacking this procedures in 2015.
Conclusions
The collaboration with the laboratories has contributed to the awareness of the laboratories to work in a quality environment. Close monitoring, adjustment and support by the IPH and the commission of anatomic pathology improved and is still improving the implementation of a quality management system as stated in the RD on licensing conditions of the Belgian laboratories for anatomic pathology.