Neurological registry quality control and quality assurance.

This section of the guideline discusses procedures and best practices around quality control and quality assurance. In developing this section of the guideline we reviewed available literature and best practice; consulted with registry and disease experts; and derived consensus recommendations. Quality, as defined by the International Standards Organization (ISO) in standard ISO 8402:1994, is the “totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.”194 In the context of registries, this means that registry data characteristics must altogether satisfy the intended and implied needs of the registry purpose. For example, if the purpose of your registry is to study all female adults of child-bearing age with epilepsy; then your registry data must consist only of female adults of child-bearing age who have a diagnosis of epilepsy. It is important to note that quality and registry purpose are inherently related. Registry creators will therefore need to define what quality means for their specific purpose(s). While quality control and quality assurance are related concepts it is important to understand that they are different. Quality assurance (QA) is the process that maintains a desired level of quality.195 QA is a proactive process done in advance of obtaining an outcome. Examples of QA activities might include audits, training, procedure documentation, selection of quality tools etc. Quality control (QC) is the assessment of whether an outcome meets quality expectations.195 QC is a reactive process done once an outcome has been obtained. Examples of QC activities might include testing a product sample to determine if it meets requirements; or conducting a site inspection visit. Useful registries must have good quality data.196,197