Re: [Histonet] grossing of skin biopsies (again)

From:"Lance Erickson"

Take a look at the CLIA website for federally regulated personnel qualification guidelines here: http://www.cms.hhs.gov/clia/apcsubm.pdf 

Basically it dictates that performing gross dictation in any form is considered high complexity testing. Specifics for the number of hours of classes is found there. 493.1489 - On or before April 24 1995 (I) be a high school graduate or equivalent; and (b) have documentation of training appropriate for the test performed before analyzing patient specimens. After that date it requires an associate degree in a biological or chemical science or medical laboratory technology -or- qualify as a medical technologist with a bachelor's degree from an accredited institution -or- earned a bachelor's degree in a chemical, physical, biologic or clinical laboratory science.

Interpretive Guidelines 493.1489(b)(7)In the case of gross examinations, the technical supervisor may delegate to individuals qualified under =A7493.1489 the responsibility for the physical examination/description, including color, weight, measurement and other characteristics of the tissue; or other mechanical procedures for which a specific written protocol has been developed. The technical supervisor is ultimately responsible for the diagnosis related to the gross examination and must sign the examination report. The technical supervisor is not required to provide direct onsite supervision but is responsible for the accuracy of all test results reported. All physical examinations/descriptions of tissue including color, weight, measurement and other characteristics of the tissue; or other mechanical procedures performed in the absence of the technical supervisor by individuals qualified under 493.1489 should be reviewed within 24 hours by the technical supervisor. All microscopic tissue examinations must be performed by individuals qualified under =A7493.1449(b), (l) or (m), as appropriate.

This is for CLIA certified laboratories. The state of Florida may have more guidlines.

Lance Erickson
Anatomic Pathology Supervisor
Primary Children's Medical Center
Salt Lake City, UT 

>>>  04/21/05 2:45 PM >>>
I asked this question about 7 weeks ago but didn't get any clear definitive answers, so here I go again. Does anyone know what the requirements are for a tech to gross skin biopsies? We are a private dermpath lab in Florida. I need to know the educational and licensing requirements as I am seeking to fill a position. All help is greatly appreciated.
Thanks,
Ron Martin

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