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Table 3 Illegibility criteria for the selection of the Belgian Reference laboratories

From: Belgian rare diseases plan in clinical pathology: identification of key biochemical diagnostic tests and establishment of reference laboratories and financing conditions

Main aspects

Criteria to be met

Evaluation procedure

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

  1. RL reference laboratory, SI International System of Units, TAT Turnaround Time
  2. aFor analyses made in Belgium, the TAT corresponds to the time period between the reception of the sample by the laboratory and the moment at which the clinician receives the validated results; for analyses outsourced abroad, it corresponds to the time period between the test prescription and the moment at which this clinician receives the validated results