QC Explained 1.0 - Quality Control for Point of Care Testing

ISO 15189 states that “Quality Control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result”. Therefore, when implementing a QC strategy for POCT devices the risk of harm to the patient should be the foundation of the plan: where and why do errors occur and what are the consequences of an erroneous result to the patient? It is important to balance the risk of harm to the patient with the stringency of the QC procedure applied. Inaccurate results can have serious implications for the patient including misdiagnosis and/or inappropriate or incorrect medical procedures being carried out unnecessarily, resulting in monetary implications for the hospital.