There are three types of evaluation requests for medical biology analysis, such as:
- Introduction of a new medical biology analysis;
- Repatriation of an analysis done outside Québec;
- Re-evaluation of an analysis already registered in the Répertoire.
The evaluation of medical biology analysis comprises six steps in two stages:
Stage I: Evaluation of the clinical relevance of the analysis
1. Evaluation of clinical relevance (INESSS);
2. Transmission of preliminary recommendation to MSSS (INESSS)
3. Designation of laboratories who offer the test (MSSS)
Stage II: Evaluation of analytical validity (if relevance is proven)
4. Developpement of technique and analytical validation (designated facility)
5. Evaluation of analytical validity (INESSS)
6. Transmission of final recommendations to MSSS (INESSS)
Any request for addition or modification to the Répertoire québécois et système de mesure des procédures de biologie médicale must be sent, by the applicant, to the Direction de la biovigilance et de la biologie médicale (DBBM) of the Ministry of Health and Social Services.
To make a request, the laboratory must address it to the DBBM (email@example.com). Upon receipt of the request, the DBBM ensures that everything is consistent and determines which actions are required. In which case, ministerial authorities transmit the request to INESSS for evaluation.
Stage I consists of evaluating the relevance of the test as well as its clinical use. Evaluation is supported by the following criteria:
- Diagnostic, prognostic or therapeutic values;
- Budgetary impact;
- Ethical, social, and organisational issues pertaining to care.
The evaluation is achieved by scientific professionals of INESSS and reviewed by members of the scientific community of medical biology analyses (CSABM). External experts are also called to collaborate.
Following this evaluation, INESSS transmits to the MSSS a preliminary notice concerning the relevance of the analysis. The MSSS is then able to decide which facility will be responsible to develop and offer the test. A temporary designation will then be made by the MSSS. When the designated laboratory by the MSSS will have developed and validated the test, the local validation data (or verification in cases of commercial kits) will be used to begin Stage II.
Stage II consists of evaluating the analytical validity of the test and the measures of quality assurance proposed by the designated laboratory. This step evaluates the reliability of the results collected and determines the limits of the analysis. The validation and verification data are presented to the CSABM who then formulate the final recommendation. Two recommendations are possible:
- Introduction to the analysis on the Répertoire;
- Refusal of introduction.
The recommendations are adopted by the chief executive officer of INESSS and transmitted to the Ministry of Health and Social Services.
The Ministry of the Health and Social Services, with whom the decision to make available the analysis lies, considers the recommendations by INESSS in order to decide whether to go ahead with the addition to the Répertoire or not.
When the update is completed, the Répertoire québécois et système de mesure des procédures de biologie médicale is published by the MSSS. Also, INESSS publishes, on its website, the Notice submitted to the Minister that gives accountability to the recommendations and gives reasons therefor.