[Histonet] New CAP grossing guidelines

Mahoney,Janice A Janice.Mahoney <@t> alegent.org
Wed Mar 31 14:44:13 CDT 2010

Is anyone concerned about the new (old) grossing personnel guidelines from CAP.  Many labs use people to "process " tissue.  No more!

ANP.11610 Phase II

If individuals other than a pathologist or pathology resident assist in gross examinations, do such individuals qualify as high complexity testing personnel under CLIA regulations?

NOTE: The laboratory director may delegate the dissection of specimens to non-pathologist individuals; these individuals must be qualified as high complexity testing personnel under CLIA regulations. The minimum training/experience required of such personnel is:

 1.  An earned associate degree in a laboratory science or medical laboratory technology, obtained from an accredited institution, OR
 2.  Education/training equivalent to the above that includes at least 60 semester hours or equivalent from an accredited institution. This education must include 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that includes 6 semester hours of chemistry, 6 semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination. In addition, the individual must have laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLA, or other organization approved by HHS (note that this training may be included in the 60 semester hours listed above), OR at least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing.

The CLIA regulations on high complexity testing personnel may be found at HC Testing Personnel<http://wwwn.cdc.gov/clia/regs/subpart_m.aspx>.

In addition, the CLIA regulations include exceptions for grandfathered individuals; these regulations (42CFR493.1489 and 1491) may be found at the above Web address and at Grandfathered Exceptions<http://wwwn.cdc.gov/clia/regs/subpart_m.aspx>.

It is the responsibility of the laboratory director to determine whether an individual's education, training and experience satisfies the requirements of this checklist question.
Jan Mahoney
Omaha, NE

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