Experience at Italian National Institute of Health in the quality control in telemedicine: tools for gathering data information and quality assessing

The authors proposed a set of tools and procedures to perform a Telemedicine Quality Control process (TM-QC) to be submitted to the telemedicine (TM) manufacturers. The proposed tools were: the Informative Questionnaire (InQu), the Classification Form (ClFo), the Technical File (TF), the Quality Assessment Checklist (QACL). The InQu served to acquire the information about the examined TM product/service; the ClFo allowed to classify a TM product/service as belonging to one application area of TM. The TF was intended as a technical dossier of product and forced the TM supplier to furnish the only requested documentation of its product, so to avoid redundant information. The QACL was a checklist of requirements, regarding all the essential aspects of the telemedical applications, that each TM products/services must be met. The final assessment of the TM product/service was carried out via the QACL, by computing the number of agreed requirements: on the basis of this computation, a Quality Level (QL) was assigned to the telemedical application. Seven levels were considered, ranging from the Basic Quality Level (QL1- B) to the Excellent Quality Level (QL7-E). The TM-QC process resulted a powerful tool to perform the quality control of the telemedical applications and should be a guidance to all the TM practitioners, from the manufacturers to the expert evaluators. The quality control process procedures proposed thus could be adopted in future as routine procedures and could be useful in the assessing the TM delivering into the National Health Service versus the traditional face to face healthcare services.