Fixation on Histology

What is CLIA, anyway? Those of us in the laboratory field hear about CLIA and CLIA regulations all the time, but what exactly are they? And how do they concern us as histology professionals?

What is CLIA?

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. Tests are determined by a scoring system based on knowledge, experience, training, and required supplies, to have a level of complexity. Tests with the lowest scores are considered waived, moderate testing scores are considered moderate complexity, and tests with the highest scores are high complexity. Laboratory personnel need to meet minimum education and training factors to do testing of moderate and high complexity. The Clinical Laboratory Improvement Advisory committee is made up of laboratory experts, including ex officio members of the three divisions that make up the committee: CMS, the CDC, and the FDA.

What does all of this mean for us that work in histology?

Unfortunately, at the current time, it doesn’t mean anything! According to CLIA standards, histology is considered “processing”, not testing. It is not considered testing because we do not provide any sort of interpretation. While we do all of the processing of the samples (processing, embedding, microtomy, and staining), it is the pathologist that is considered the testing personnel because they provide an interpretation. This means that no aspect of histology is assigned a complexity; not even special stains or IHC. Remember though, that is applies to histology in the strictest sense. Some of you may do grossing, which is considered high complexity.

Since no area of histology is considered to be testing, this means that histology is not under CLIA oversight. Of course, many of our labs are accredited by CAP and JHACO, and they have their own standards to meet regarding laboratory personnel. But it remains that CLIA regulations regarding complexity do not apply to histology.

How do we change things?

NSH is advocating for the histology profession. When CMS requested information about CLIAC looking at laboratory personnel requirements, we jumped at the chance to be heard. The NSH Board of Directors created a task force to deliver a formal comment during the open comment period. This letter may be found here. Essentially, we asked that CLIA consider bringing histology under their oversight, and assigning complexities to the various tasks we do on a regular basis. CLIAC decided to form a working group to further discuss our proposal and other laboratory personnel issues brought to their attention by CMS.

Stay tuned for part two of this post, which will discuss the recent CLIAC meeting, where I presented NSH's position on laboratory personnel requirements.