Representation Under CLIA

Representation for Histology Under CLIA

Q: What is CLIA?

A: CLIA (The Clinical Laboratory Improvement Amendments of 1988) are regulations are federal standards for facilities that test human specimens in health assessment. The regulations use a scoring system to provide a complexity level to various tests performed at these sites, based on the knowledge, experience, training, and supplies required to perform them. 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. Learn More.

Q: Why is CLIA important for histologists?

A: Currently, histology is not addressed at all under the CLIA regulations. As a result, the tests we perform are not classified as complex, despite the nature of some of our tests growing increasingly complex. This limits histotechnologists’ ability to fight for higher pay, proper training, and recognition within the laboratory as a valuable profession. Learn more.

Q: What is CLIAC?

A: CLIAC (Clinical Laboratory Improvement Advisory Committee) is made up of laboratory experts from CMS, the CDC, and the FDA. In 2018, CMS put out a request for information, asking for comments on personnel requirements, so that CLIAC could investigate them. NSH responded to that request for information, with our suggestion that histology be brought under the oversight of CLIA. CLIAC then formed a task force to further investigate our proposal, and the other comments brought to them during the RFI. Learn more.

Q: What was NSH’s response to the CMS RFI?

A: NSH urges that the CLIA recommendations be amended to include histotechs under CLIA’s oversight. In addition, NSH is proposing that histotechnicians and histotechnologists be required to pass an accredited certification examination for laboratory personnel performing pre-examination through post-examination processes in histopathology laboratories. To prevent the requirement from becoming onerous, and to address workforce shortage concerns, NSH proposes that on the job trained non-certified technicians with at least five years’ experience in a CLIA certified laboratory at the time that the new regulations go into effect, be given five years to continue to work and obtain the required high complexity certification. During this five-year transition period un-certified techs must work under the direct supervision of a certified technician. Read the full NSH response here.

Histotechs Discussing Policy at NSH Convention

NSH Responds to CMS Request for Information

Luis Chiriboga and Amanda Kelley