Main aspects | Criteria to be met | Evaluation procedure |
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Localisation, structure, organization and governance | Applicants are laboratories of clinical pathology located in Belgium and certified according to the Royal Decree of 3 December 1999 [19] Applicants provide the full contact details of the laboratory, its director, quality coordinator and of the clinical pathologist(s) responsible for the performance of the analysis for which they apply Applications in the form of a consortium have to be justified A clear description of the tasks performed by each laboratory composing the consortium must be provided | Documentation audit On-site visits for RL in the form of a consortium |
Quality | Applicants have to join the following documents to the application file: Full content of the laboratory quality manual Description of the method and equipment used to perform the analysis (Standard Operating Procedure) Analysis validation file (including the reference values and bibliographic references used to validate the method and interpret analytical results) Description of the External Quality Assessment programs and/or ring tests related to the analysis for which they apply and to which they participate Copy of the laboratory accreditation certificate according to the norm ISO15189 [20] | Documentation audit On-site visits |
Reporting of analytical results and communication skills | Applicants have to specify: The units used to report the results and if those units are SI units or not (if not, they also have to mention the reason) Their mean turnaround time (TAT)a for the analysis for which they apply (expressed in days, with a standard deviation if desired) The link to their website where the prescribers can find the analytical TAT If they undertake to respect the TAT mentioned on their website/prescription forms If they undertake to be more flexible and reduce their TAT for urgent analyzes in order to guarantee the good management of the patient If they are able to report the results in at least one of the Belgian national languages and in English If they accept to publish the prescription forms in French, Dutch and English on their website If they accept that information related to their activities (no patients details/personal information) will be used to update and enrich the Belgian rare diseases registries | Documentation audit |
Scientific and medical expertise | Applicants have to provide: Their annual volume of tests during the 5 last years for the analysis for which they apply Their list of scientific communications (peer-reviewed publications, posters, etc.) related to rare diseases management A short description of their projects in the domain of clinical pathology to which the analysis for whom they apply belongs (basic research projects, clinical research, epidemiological research, validation of new methods, acquisition of new equipment, etc.) Their affiliations to international (reference) networks with a short description of the (1) network spectrum of activities, (2) applicants duties/activities within the network, and (iii) frequency of applicants’ meetings/exchanges of information with other network members The names of the databases in which analytical results are recorded (patient’s medical record, laboratory database, Regional/national database, network database, etc.) A description of their participation to multidisciplinary meetings (frequency, medical disciplines [specializations] of the experts who attended the meetings, aspects discussed during the meetings [clinical cases, analytical results interpretation, communication between the laboratory and prescribers, development of guidelines/healthcare algorithms, etc.]) A description of the diagnosis and/or follow-up guidelines/algorithms that they may develop for some rare diseases A description of the training programs that they develop and of the targeted audience | Documentation audit |
Activities sustainaibility | Candidates undertake to carry out the analysis for which they apply for at least 5 years in the case of a recognition as RL and confirm that they possess the necessary qualified personnel, equipment and infrastructure to carry out the analysis during this period of time | Documentation audit |