This came up during a recent CAP inspection of a lab we inspected in Maricopa so I have taken the liberty of copying the information from the CAP guidelines regarding this issue for you. The first question defines high complexity testing and the second question addresses requirements for individuals performing these tasks.
Hope this helps, have a great weekend!
According to CAP guidelines
"Are all macroscopic tissue examinations performed by a pathologist or pathology resident, or under supervision of a qualified pathologist?
Note: Two levels of complexity of macroscopic tissue examination are defined, as follows:
1. Processing is defined as a tissue examination limited to description, inking and cutting of the specimen (if applicable), and submission of the entire specimen to histology. Tissue processing can be performed accroding to standardized protocols. Processing is generally limited to small specimens (skin ellipses, small biopsies, curettings, etc.) and does not require knowledge of anatomy.
2. Grossing (or gross examination) is defined as a tissue examination requiring a greater exercise of judgement and a knowledge of anatomy. Dissection of the specimen and selection of tissue samples for submission to histology are generally required. The specimen description is not necessarily stadardized.
"If individuals other than a pathologist or pathology resident assist in gross examinations, do such individuals qualify as high complexity testing personnel under CLIA-88 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-88 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, the CAHEA, 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.
In addition, the CLIA-88 regulations include exceptions for grandfathered individuals; these regulations (42CFR493.1489 and 1491) may be found at http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493=2E1487
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.
This checklist question applies only to laboratories subject to CLIA-88
Lia M. Caldwell HT (ASCP)
Oro Valley Pathology Dept.
phone: (520) 901-3914
"be yourself - everyone else is already taken." -unknown
From: email@example.com on behalf of Sharon.Davis-Devine
Sent: Fri 8/22/2008 10:23 AM
Subject: [Histonet] Training for gross
=0DFor all of you Histonetters out there I have a question about training
individuals to gross in small specimens. Can a person with a degree and
being a Cytotechnologist, Medical Technologist or a Histotechnologist
gross in small biopsy samples? And if they can, what kind of training
is required and for how long? We are losing one of our PA's and are
contemplating replacing that person with a person with a degree=2E Thanks
for the info.
Sharon Davis-Devine, CT (ASCP)
=0A602 West University
Urbana, Illinois 61801
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