Histopathology Grossing - Individual Qualifications

Can a non-pathologist perform grossing of histopathology specimens?

Any examples are for illustrative purposes only

Yes, when the individual is qualified under the Clinical Laboratory Improvement Amendments (CLIA) and state law, whichever is more stringent. Under CLIA, the individual must be qualified to perform high complexity testing by one of the routes defined at 42 CFR 493.1489. In summary, the minimum qualification route for high complexity testing is an associate's degree in a science with orientation, training and annual competency assessment (semiannual for the first year). In addition, the pathologist must define in writing the grossing activities the individual is permitted to perform and the specimen types. The pathologist must also review the individual's work within 24-hours and provide feedback on their performance as part of an ongoing quality assurance activity. Please the CLIA Regulations .
Last updated on April 29, 2020
Manual: Laboratory
Chapter: Quality System Assessment for Nonwaived Testing QSA

If no, please comment on how we could improve this response.

If you have additional standards-related questions regarding this topic, please use the Standards Online Submission Form