Special Commentary: The Cost of Maintaining Diagnostic Accuracy in Laboratory Testing

Abstract

In the healthcare industry, there seems to be a nebulous notion regarding what a clinical laboratory actually is and does. Many seem to think it consists of a big black box where specimens are put in and results come out. The reality, however, is much more complex. An average hospital clinical laboratory consists of hundreds of trained staff working 24 hours a day, 365 days per year processing specimens, maintaining instruments and running quality checks, and performing manual, and highly specialized, diagnostic testing on every single type of specimen imaginable.

While laboratory medicine continues to evolve, one crucial aspect of operations has stayed consistent over time – the qualifications of laboratory personnel. However, as the shortage of healthcare personnel continues, the landscape of quality is changing. On April 1, 2016, CMS published guideline S&C: 16-18-CLIA, which is a revision of previous standards of the qualifications needed to perform laboratory testing. The guideline particularly states, “Bachelor’s and Associate’s degrees in nursing meet the requirement for earning a degree in a biological science for, respectively, high complexity testing personnel and moderate complexity testing personnel.”¹

While nursing staff is an indispensable part of the healthcare team, their education does not meet the biological science requirements to give nurses enough knowledge to perform moderate and high complexity laboratory testing to the standards to under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88).