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). Competence will be assessed annually using all applicable methods referenced in Joint Commission Human Resources (HR) standards and CLIA regulations. 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 .
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). Competence will be assessed annually using all applicable methods referenced in Joint Commission Human Resources (HR) standards and CLIA regulations. 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 .
Manual:
Laboratory
Chapter:
Quality System Assessment for Nonwaived Testing QSA
First published date: April 11, 2016
This Standards FAQ was first published on this date.
This page was last updated on June 13, 2022
with update notes of: Editorial changes only
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