Internal Quality Control in the Hemostasis Laboratory

Many tests performed in coagulation laboratories are vital for the accurate diagnosis and safe management of patients with familial and acquired bleeding and thrombotic disorders. It is particularly important that results are accurate and reliable when investigations are undertaken to determine possible familial disorders of hemostasis. A laboratory error may lead to misdiagnosis, and whether an error leads to a subject being misdiagnosed as having, or not having, a familial defect, there could be serious clinical consequences. Adequate internal quality control procedures are a critical part of the quality management system that seeks to ensure that test results are safe to release for patient management decisions. This chapter addresses the nature of internal quality control materials and their properties in relation to hemostasis testing, including a discussion of preparation and storage of such materials. The frequency of testing is described with reference to published guidelines as well as sections on out of limits IQC results. Readers are reminded that IQC testing and regular scrutiny of results obtained should be merely one component of the quality assurance and quality management program, and that quality control is a continuous process and is the responsibility of all staff at all levels in the hemostasis laboratory. This edition first published 2013