Quality Management of Clinical Laboratory Tests

Abstract

 Clinical laboratory tests are broadly divided into specimen tests, physiological function tests, imaging tests, and endoscopies, a unique type of test. By performing the tests believed to be required, in combination with a patient interview and examination, a physician can diagnose diseases and pathologies, administer treatment, and monitor subsequent progress. Therefore, tests play a critical role in clinical healthcare. Tests constitute large portions of health checkups because these subjects include individuals without any symptoms. Therefore, these tests must be performed adequately to gain the patient's or subject's trust. Thus, high test precision and accuracy are required. These qualities are ensured through precision management, including internal and external quality control. Internal quality control involves daily management performed in a facility or laboratory, while external quality control involves cross-facility management, i.e., checking how the data of one's facility compares with those of other facilities. External quality control would be meaningless without internal quality control. This paper discusses internal and external quality control. Quality control has become commonplace in general widely-used sample tests, such as blood, urine, and stool tests; however, physiological function tests and imaging tests also require quality control. This is also true for bedside point-of-care testing (POCT); this paper also discusses its current status. Data focusing in sample testing is very good, owing to advancements in machines and reagents, however the internal quality control of daily laboratory tasks requires an attitude of constant attention to the data, without relying on machines. This paper will also elucidate the status of external quality control projects within this academic society and evaluate their importance. These days, there is a loud call for precision assurance in the laboratory, as in ISO15189 and the "Quality Control" in medical methods. We hope that this paper reveals more information regarding these topics.