Does a Gap in Quality Control Practice Create a Gap in Patient Care?

摘要

Millions of laboratory results are reported on patients every day. All those results can be put into 3 "pots" from a quality perspective: they are (1) right, (2) close enough to right, or (3) wrong. If results are right, or close enough to right, physicians can reach the correct clinical interpretation and patients should get the appropriate treatment. If results are wrong: (1) patients may be falsely diagnosed as having a disease or condition they do not have, (2) diagnosis of a serious condition may be missed, or (3) a change in serial results may be misinterpreted and inappropriate treatment changes made or missed. Laboratories invest a significant amount of time, effort, and money to perform quality control. In theory, these efforts assure regulators, administrators, clinicians, and patients that reported results are of sufficient accuracy, precision, sensitivity, specificity, and overall quality to meet clinical quality requirements. A prevailing attitude has developed that "quality is a given." But what level of quality are laboratories actually controlling? Can your laboratory guarantee that reported results are close enough to right so clinicians can always reach the right clinical interpretation? The theories that have been recommended and endorsed by scientific experts have not been well implemented in practice. Such a gap can cause results to be reported too far from their right value to enable clinicians to reach the right clinical interpretation and thereby endanger patient care.