Abstract Background Biomarkers are used in the clinical laboratory for routine patient care, and in the pharmaceutical industry during drug development, and in establishing safety and efficacy of a candidate drug. Biomarkers are also used in clinical and epidemiologic research…
Abstract Background Biobanks may be established for nonresearch purposes, such as diagnostic, therapeutic, treatment, forensic, transplantation, and transfusion, or for research purposes as part of epidemiologic studies and clinical trials. Biobank planning is essential for biospecimen integrity in support of…
Abstract Background Evidence-based laboratory medicine (EBLM) is an approach to medical practice that integrates the best available research evidence about laboratory investigations with the clinical expertise of clinicians, to improve the health and health care outcomes of individual patients. Practicing…
Abstract Background One of the most important elements of a laboratory test result is the reference interval, a set of values against which physicians compare their patients’ test results, facilitating interpretation. It is extremely important, therefore that the laboratory community…
Abstract Background There are many sources of variation in numerical results generated by examinations performed in laboratory medicine. Some measurands have biological variations over the span of life and others have predictable cyclical or seasonal variations. Most measurands in an…
Abstract Background The purpose of a clinical laboratory test is to provide information on the pathophysiologic condition of an individual patient to assist with diagnosis, to guide or monitor therapy, or to assess risk for a disease. Results for the…
Abstract Quality control (QC), also called internal QC, monitors a measurement procedure to verify that results for patient samples meet performance specifications appropriate for patient care or that an error condition exists that must be corrected. QC samples are measured…
Abstract Background The preanalytical phase has long been recognized as a source of substantial variability in laboratory medicine. Laboratory errors, mostly due to some defect in the preanalytical phase, may lead to diagnostic errors. Understanding preanalytical variation and reducing errors…
Abstract Background Proper specimen collection and processing are critical to avoiding common preanalytical errors and ensuring accurate test results. Specific steps, recommendations, and procedures are designed to protect both the patient and the individual collecting the specimen. Content This chapter…
Abstract The aspirational goal of diagnostic pathology laboratories is to always provide the right result for the right test on the right patient at the right time and with the right support. To deliver this outcome systematically, reliably, and safely…