CLIA regs for grossing of tissues

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From:"Jennings-Siena, Debbie" <> (by way of histonet)
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I erased the person's message that was asking about CLIA regulations for
HT's do gross examination of tissues by mistake.  However, since this has
come up several times lately, I will try to let you all know what I have
about HT's doing gross and what constitutes high complexity testing as far
as CLIA'88 is concerned:

Gross Examination of Tissue (section 493.1461 (e) and Section 493.1489 (b)
(c) Guidelines-
The Technical supervisor (Pathologist) may delegate to individuals qualified
under section 493.1489 the responsibility for the physician
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 section 493.1489 must be reviewed within 24
hours by the technical supervisor.  All microscopic tissue examinations must
be performed by individuals qualified under section 493.1489 (b), (l) or

Qualifications of Testing personnel (Citation 493.1489):
The laboratory must have a sufficient number of people qualified as Testing
Personnel to perform high complexity testing.  Each individual performing
high complexity testing must possess a current license issued by the state
in which the lab is located, IF SUCH licensing is required; AND meet one of
the following requirements:

	* Be an MD in the state in which the laboratory is located or have
earned a doctoral, 	master's, bachelor's degree in chemistry, physical,
biological or clinical laboratory 	science, or medical technology from
an accredited institution; or

	*have earned an associate degree in a chemical, physical or
biological science or 	medical laboratory technology from an accredited
institution; or

	*have previously qualified or could have qualified as a technologist
under the March 	14, 1990 Final rule (CLIA '67) on or before February
28, 1992 (i.e. passed the HHS 	proficiency exam); or

	*on or before April 24, 1995 be a high school graduate or equivalent
and have either 	graduated from a medical laboratory or clinical
laboratory training program approved 	by ABHES, CAHEA, or other
organization approved by HHS or successfully 	completed an official US
military medical laboratory training course of at least 50 	weeks
duration and have held the military enlisted occupational specialty of
Medical 	Laboratory Specialist; or

	*Until September 1, 1997-have earned an academic high school diploma
or equivalent; 	and have documentation of training appropriate for the
testing performed prior to 	analyzing patient specimens.  Such training
must ensure that the individual has:

	-the skills required for proper specimen collection, including
patient preparation, if 	applicable, labeling, handling, preservation
or fixation, processing or preparation, 		 transportation and
storage of specimens;
	-the skills required for implementing all standard laboratory
	-the skills required for performing each test method and for proper
instrument use;
	-the skills required for performing preventative maintenance,
troubleshooting and 	 calibration procedures related to each test
	-a working knowledge of reagent stability and storage;
	-the skills required to implement the quality control policies and
procedures of the 	 laboratory.
	- an awareness of the factors that influence test results; and
	-the skills required to assess and verify the validity of patient
test results through the 	 evaluation of quality control sample values
prior to reporting patient test results.

As of September 1, 1997, testing personnel must have an associate's degree,
as specified previously, to continue testing.  However, the April 24, 1995
final rule grandfather's personnel performing high complexity testing on or
before April 24, 1995---these individuals did not need to meet additional
training or education requirements to continue performing testing.

Debbie J. Siena
NSH Legislative Chair
Baylor University Medical Center

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